Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)
Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR...
Gespeichert in:
| Veröffentlicht in: | The American heart journal 2024-07, Vol.273, p.121-129 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 129 |
|---|---|
| container_issue | |
| container_start_page | 121 |
| container_title | The American heart journal |
| container_volume | 273 |
| creator | Wegerif, Emilien C.J. Ünlü, Çağdaş Generaal, Manon I. van den Bor, Rutger M. van de Ven, Peter M. Bots, Michiel L. de Borst, Gert J. |
| description | Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has been proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted.
CLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75 mg plus placebo) with DAPT (clopidogrel 75 mg plus acetylsalicylic acid 80 mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis in Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months.
CLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients.
: NL80009.041.21. |
| doi_str_mv | 10.1016/j.ahj.2024.04.001 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3038441367</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0002870324000802</els_id><sourcerecordid>3065602998</sourcerecordid><originalsourceid>FETCH-LOGICAL-c424t-a27e6b6298a37f476e2b09d619261ad37f1bcae706640ec28c0fab79e9555e873</originalsourceid><addsrcrecordid>eNqFkkGP0zAQhQMCsWXhB3BBlri0h3TtJHUS7amqdllQJdBqOUeOPWldOXGwnUL49TtpFw4cQHJkZfTNmzfJi6J3jC4ZZfzqsBT7wzKhSbakeCh7Hs0YLfOY51n2IppRSpO4yGl6Eb32_oCvPCn4q-giLTgtyjKfPft8L4K2nTBARKeIAq93HWmsI2EPxGHNtvoXKNIbIaG2sbRdcNYYLCk71Abi2mjsDE4LQ3wY1Ki73akbmgZkILYhHkunCUGjTgADYSKc6Ecyl8b2WtmdA7MgR3B-8EQNKPZf_AothdF4YbQc8SFCarUgtjuNt1IOzkEnYbIgJgEb9s62tQ3IwhG64HFVY-yPyTJe4Aj8DA5aHUbSg9P9NNXgcqLzZmh1d7K10xZ9eWTmm-3N-j7-un64W7yJXjbCeHj7dF9G325vHjZ38fbLx0-b9TaWWZKFWCQ58JonZSHSvMlyDklNS8VZmXAmFNZYLQXklPOMgkwKSRtR5yWUq9UKijy9jOZn3d7Z7wP4ULXaSzBGdGAHX6U0LbKMpXxCP_yFHuzgcImJ4itOk7IskGJnSjrrvYOm6p1uhRsrRqspaNWhwqBVU9Aqiocy7Hn_pDzULag_Hb-ThcD1GQD8FEcNrvJSTz9DaYepqJTV_5B_BATI7T8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3065602998</pqid></control><display><type>article</type><title>Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><source>ProQuest Central UK/Ireland</source><creator>Wegerif, Emilien C.J. ; Ünlü, Çağdaş ; Generaal, Manon I. ; van den Bor, Rutger M. ; van de Ven, Peter M. ; Bots, Michiel L. ; de Borst, Gert J.</creator><creatorcontrib>Wegerif, Emilien C.J. ; Ünlü, Çağdaş ; Generaal, Manon I. ; van den Bor, Rutger M. ; van de Ven, Peter M. ; Bots, Michiel L. ; de Borst, Gert J.</creatorcontrib><description>Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has been proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted.
CLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75 mg plus placebo) with DAPT (clopidogrel 75 mg plus acetylsalicylic acid 80 mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis in Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months.
CLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients.
: NL80009.041.21.</description><identifier>ISSN: 0002-8703</identifier><identifier>ISSN: 1097-6744</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2024.04.001</identifier><identifier>PMID: 38608997</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acetylsalicylic acid ; Amputation ; Angioplasty ; Angioplasty - methods ; Anticoagulants ; Antiplatelet therapy ; Aspirin ; Aspirin - administration & dosage ; Aspirin - therapeutic use ; Bleeding ; Cardiovascular disease ; Cardiovascular system ; Cerebral infarction ; Cerebrovascular diseases ; Clopidogrel ; Clopidogrel - administration & dosage ; Clopidogrel - therapeutic use ; Coronary artery ; Double-Blind Method ; Double-blind studies ; Dual Anti-Platelet Therapy - methods ; Effectiveness ; Female ; Heart attacks ; Hemorrhage - chemically induced ; Hemorrhage - epidemiology ; Human subjects ; Humans ; Ischemia ; Lower Extremity - blood supply ; Male ; Males ; Medical research ; Mortality ; Myocardial infarction ; Netherlands - epidemiology ; Occlusion ; Patient compliance ; Peripheral Arterial Disease - therapy ; Placebos ; Platelet Aggregation Inhibitors - administration & dosage ; Platelet Aggregation Inhibitors - therapeutic use ; Population studies ; Prospective Studies ; Quality of life ; Questionnaires ; Restenosis ; Therapy ; Thrombolysis ; Thrombosis - epidemiology ; Thrombosis - etiology ; Thrombosis - prevention & control ; Vascular diseases ; Vein & artery diseases</subject><ispartof>The American heart journal, 2024-07, Vol.273, p.121-129</ispartof><rights>2024 The Author(s)</rights><rights>Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.</rights><rights>2024. The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-a27e6b6298a37f476e2b09d619261ad37f1bcae706640ec28c0fab79e9555e873</citedby><cites>FETCH-LOGICAL-c424t-a27e6b6298a37f476e2b09d619261ad37f1bcae706640ec28c0fab79e9555e873</cites><orcidid>0000-0002-9849-439X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/3065602998?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38608997$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wegerif, Emilien C.J.</creatorcontrib><creatorcontrib>Ünlü, Çağdaş</creatorcontrib><creatorcontrib>Generaal, Manon I.</creatorcontrib><creatorcontrib>van den Bor, Rutger M.</creatorcontrib><creatorcontrib>van de Ven, Peter M.</creatorcontrib><creatorcontrib>Bots, Michiel L.</creatorcontrib><creatorcontrib>de Borst, Gert J.</creatorcontrib><title>Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has been proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted.
CLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75 mg plus placebo) with DAPT (clopidogrel 75 mg plus acetylsalicylic acid 80 mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis in Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months.
CLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients.
: NL80009.041.21.</description><subject>Acetylsalicylic acid</subject><subject>Amputation</subject><subject>Angioplasty</subject><subject>Angioplasty - methods</subject><subject>Anticoagulants</subject><subject>Antiplatelet therapy</subject><subject>Aspirin</subject><subject>Aspirin - administration & dosage</subject><subject>Aspirin - therapeutic use</subject><subject>Bleeding</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular system</subject><subject>Cerebral infarction</subject><subject>Cerebrovascular diseases</subject><subject>Clopidogrel</subject><subject>Clopidogrel - administration & dosage</subject><subject>Clopidogrel - therapeutic use</subject><subject>Coronary artery</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Dual Anti-Platelet Therapy - methods</subject><subject>Effectiveness</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Hemorrhage - chemically induced</subject><subject>Hemorrhage - epidemiology</subject><subject>Human subjects</subject><subject>Humans</subject><subject>Ischemia</subject><subject>Lower Extremity - blood supply</subject><subject>Male</subject><subject>Males</subject><subject>Medical research</subject><subject>Mortality</subject><subject>Myocardial infarction</subject><subject>Netherlands - epidemiology</subject><subject>Occlusion</subject><subject>Patient compliance</subject><subject>Peripheral Arterial Disease - therapy</subject><subject>Placebos</subject><subject>Platelet Aggregation Inhibitors - administration & dosage</subject><subject>Platelet Aggregation Inhibitors - therapeutic use</subject><subject>Population studies</subject><subject>Prospective Studies</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Restenosis</subject><subject>Therapy</subject><subject>Thrombolysis</subject><subject>Thrombosis - epidemiology</subject><subject>Thrombosis - etiology</subject><subject>Thrombosis - prevention & control</subject><subject>Vascular diseases</subject><subject>Vein & artery diseases</subject><issn>0002-8703</issn><issn>1097-6744</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkkGP0zAQhQMCsWXhB3BBlri0h3TtJHUS7amqdllQJdBqOUeOPWldOXGwnUL49TtpFw4cQHJkZfTNmzfJi6J3jC4ZZfzqsBT7wzKhSbakeCh7Hs0YLfOY51n2IppRSpO4yGl6Eb32_oCvPCn4q-giLTgtyjKfPft8L4K2nTBARKeIAq93HWmsI2EPxGHNtvoXKNIbIaG2sbRdcNYYLCk71Abi2mjsDE4LQ3wY1Ki73akbmgZkILYhHkunCUGjTgADYSKc6Ecyl8b2WtmdA7MgR3B-8EQNKPZf_AothdF4YbQc8SFCarUgtjuNt1IOzkEnYbIgJgEb9s62tQ3IwhG64HFVY-yPyTJe4Aj8DA5aHUbSg9P9NNXgcqLzZmh1d7K10xZ9eWTmm-3N-j7-un64W7yJXjbCeHj7dF9G325vHjZ38fbLx0-b9TaWWZKFWCQ58JonZSHSvMlyDklNS8VZmXAmFNZYLQXklPOMgkwKSRtR5yWUq9UKijy9jOZn3d7Z7wP4ULXaSzBGdGAHX6U0LbKMpXxCP_yFHuzgcImJ4itOk7IskGJnSjrrvYOm6p1uhRsrRqspaNWhwqBVU9Aqiocy7Hn_pDzULag_Hb-ThcD1GQD8FEcNrvJSTz9DaYepqJTV_5B_BATI7T8</recordid><startdate>202407</startdate><enddate>202407</enddate><creator>Wegerif, Emilien C.J.</creator><creator>Ünlü, Çağdaş</creator><creator>Generaal, Manon I.</creator><creator>van den Bor, Rutger M.</creator><creator>van de Ven, Peter M.</creator><creator>Bots, Michiel L.</creator><creator>de Borst, Gert J.</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9849-439X</orcidid></search><sort><creationdate>202407</creationdate><title>Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)</title><author>Wegerif, Emilien C.J. ; Ünlü, Çağdaş ; Generaal, Manon I. ; van den Bor, Rutger M. ; van de Ven, Peter M. ; Bots, Michiel L. ; de Borst, Gert J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c424t-a27e6b6298a37f476e2b09d619261ad37f1bcae706640ec28c0fab79e9555e873</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Acetylsalicylic acid</topic><topic>Amputation</topic><topic>Angioplasty</topic><topic>Angioplasty - methods</topic><topic>Anticoagulants</topic><topic>Antiplatelet therapy</topic><topic>Aspirin</topic><topic>Aspirin - administration & dosage</topic><topic>Aspirin - therapeutic use</topic><topic>Bleeding</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular system</topic><topic>Cerebral infarction</topic><topic>Cerebrovascular diseases</topic><topic>Clopidogrel</topic><topic>Clopidogrel - administration & dosage</topic><topic>Clopidogrel - therapeutic use</topic><topic>Coronary artery</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Dual Anti-Platelet Therapy - methods</topic><topic>Effectiveness</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Hemorrhage - chemically induced</topic><topic>Hemorrhage - epidemiology</topic><topic>Human subjects</topic><topic>Humans</topic><topic>Ischemia</topic><topic>Lower Extremity - blood supply</topic><topic>Male</topic><topic>Males</topic><topic>Medical research</topic><topic>Mortality</topic><topic>Myocardial infarction</topic><topic>Netherlands - epidemiology</topic><topic>Occlusion</topic><topic>Patient compliance</topic><topic>Peripheral Arterial Disease - therapy</topic><topic>Placebos</topic><topic>Platelet Aggregation Inhibitors - administration & dosage</topic><topic>Platelet Aggregation Inhibitors - therapeutic use</topic><topic>Population studies</topic><topic>Prospective Studies</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Restenosis</topic><topic>Therapy</topic><topic>Thrombolysis</topic><topic>Thrombosis - epidemiology</topic><topic>Thrombosis - etiology</topic><topic>Thrombosis - prevention & control</topic><topic>Vascular diseases</topic><topic>Vein & artery diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wegerif, Emilien C.J.</creatorcontrib><creatorcontrib>Ünlü, Çağdaş</creatorcontrib><creatorcontrib>Generaal, Manon I.</creatorcontrib><creatorcontrib>van den Bor, Rutger M.</creatorcontrib><creatorcontrib>van de Ven, Peter M.</creatorcontrib><creatorcontrib>Bots, Michiel L.</creatorcontrib><creatorcontrib>de Borst, Gert J.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wegerif, Emilien C.J.</au><au>Ünlü, Çağdaş</au><au>Generaal, Manon I.</au><au>van den Bor, Rutger M.</au><au>van de Ven, Peter M.</au><au>Bots, Michiel L.</au><au>de Borst, Gert J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2024-07</date><risdate>2024</risdate><volume>273</volume><spage>121</spage><epage>129</epage><pages>121-129</pages><issn>0002-8703</issn><issn>1097-6744</issn><eissn>1097-6744</eissn><abstract>Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has been proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted.
CLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75 mg plus placebo) with DAPT (clopidogrel 75 mg plus acetylsalicylic acid 80 mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis in Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months.
CLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients.
: NL80009.041.21.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38608997</pmid><doi>10.1016/j.ahj.2024.04.001</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-9849-439X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2024-07, Vol.273, p.121-129 |
| issn | 0002-8703 1097-6744 1097-6744 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3038441367 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central UK/Ireland |
| subjects | Acetylsalicylic acid Amputation Angioplasty Angioplasty - methods Anticoagulants Antiplatelet therapy Aspirin Aspirin - administration & dosage Aspirin - therapeutic use Bleeding Cardiovascular disease Cardiovascular system Cerebral infarction Cerebrovascular diseases Clopidogrel Clopidogrel - administration & dosage Clopidogrel - therapeutic use Coronary artery Double-Blind Method Double-blind studies Dual Anti-Platelet Therapy - methods Effectiveness Female Heart attacks Hemorrhage - chemically induced Hemorrhage - epidemiology Human subjects Humans Ischemia Lower Extremity - blood supply Male Males Medical research Mortality Myocardial infarction Netherlands - epidemiology Occlusion Patient compliance Peripheral Arterial Disease - therapy Placebos Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - therapeutic use Population studies Prospective Studies Quality of life Questionnaires Restenosis Therapy Thrombolysis Thrombosis - epidemiology Thrombosis - etiology Thrombosis - prevention & control Vascular diseases Vein & artery diseases |
| title | Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-04T17%3A23%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Rationale%20and%20design%20for%20the%20randomized%20placebo-controlled%20double-blind%20trial%20studying%20the%20effect%20of%20single%20antiplatelet%20therapy%20(clopidogrel)%20versus%20dual%20antiplatelet%20therapy%20(clopidogrel/acetylsalicylic%20acid)%20on%20the%20occurrence%20of%20atherothrombotic%20events%20following%20lower%20extremity%20peripheral%20transluminal%20angioplasty%20(CLEAR-PATH)&rft.jtitle=The%20American%20heart%20journal&rft.au=Wegerif,%20Emilien%20C.J.&rft.date=2024-07&rft.volume=273&rft.spage=121&rft.epage=129&rft.pages=121-129&rft.issn=0002-8703&rft.eissn=1097-6744&rft_id=info:doi/10.1016/j.ahj.2024.04.001&rft_dat=%3Cproquest_cross%3E3065602998%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3065602998&rft_id=info:pmid/38608997&rft_els_id=S0002870324000802&rfr_iscdi=true |