Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial
Although dual antiplatelet therapy with aspirin and a potent P2Y12 receptor inhibitor is currently recommended in patients with acute coronary syndrome (ACS), its use in elderly patients remains challenging. The aim of this trial is to evaluate the pharmacodynamic and pharmacokinetic profile of tica...
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| Veröffentlicht in: | European heart journal. Cardiovascular pharmacotherapy 2024-11, Vol.10 (7), p.578-587 |
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| creator | Piccolo, Raffaele Simonetti, Fiorenzo Avvedimento, Marisa Cutillo, Maria Canonico, Mario Enrico Conti, Valeria Gargiulo, Giuseppe Paolillo, Roberta Dal Piaz, Fabrizio Filippelli, Amelia Charlier, Bruno Spinelli, Alessandra Cristiano, Stefano Cirillo, Plinio Di Serafino, Luigi Franzone, Anna Esposito, Giovanni |
| description | Although dual antiplatelet therapy with aspirin and a potent P2Y12 receptor inhibitor is currently recommended in patients with acute coronary syndrome (ACS), its use in elderly patients remains challenging. The aim of this trial is to evaluate the pharmacodynamic and pharmacokinetic profile of ticagrelor 60 vs. 90 mg twice daily among elderly patients (≥75 years) with ACS undergoing percutaneous coronary intervention (PCI).
PLINY The ELDER (NCT04739384) was a randomized, crossover trial testing the non-inferiority of a lower vs. standard dose of ticagrelor with respect to the primary endpoint of P2Y12 inhibition as determined by pre-dose P2Y12 reaction units (PRU) using the VerifyNow-P2Y12 (Accumetrics, San Diego, CA, USA). Other pharmacodynamic tests included light transmittance aggregometry, multiple electrode aggregometry, and response to aspirin. Plasma levels of ticagrelor and its active metabolite AR-C124910XX were also evaluated. A total of 50 patients (mean age 79.6 ± 4.0 years, females 44%) were included in the trial. Ticagrelor 60 mg was non-inferior to ticagrelor 90 mg according to VerifyNow-P2Y12 results (PRU 26.4 ± 32.1 vs. 30.4 ± 39.0; least squares mean difference: -4; 95% confidence interval: -16.27 to 8.06; P for non-inferiority = 0.002). Other pharmacodynamic parameters were similar between the two ticagrelor doses and there were no differences in response to aspirin. Plasma levels of ticagrelor (398.29 ± 312.36 ng/mL vs. 579.57 ± 351.73 ng/mL, P = 0.006) and its active metabolite were significantly lower during treatment with ticagrelor 60 mg.
Although plasma concentrations were lower, ticagrelor 60 mg twice daily provided a similar magnitude of platelet inhibition compared with ticagrelor 90 mg twice daily among elderly patients undergoing PCI. |
| doi_str_mv | 10.1093/ehjcvp/pvae054 |
| format | Article |
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PLINY The ELDER (NCT04739384) was a randomized, crossover trial testing the non-inferiority of a lower vs. standard dose of ticagrelor with respect to the primary endpoint of P2Y12 inhibition as determined by pre-dose P2Y12 reaction units (PRU) using the VerifyNow-P2Y12 (Accumetrics, San Diego, CA, USA). Other pharmacodynamic tests included light transmittance aggregometry, multiple electrode aggregometry, and response to aspirin. Plasma levels of ticagrelor and its active metabolite AR-C124910XX were also evaluated. A total of 50 patients (mean age 79.6 ± 4.0 years, females 44%) were included in the trial. Ticagrelor 60 mg was non-inferior to ticagrelor 90 mg according to VerifyNow-P2Y12 results (PRU 26.4 ± 32.1 vs. 30.4 ± 39.0; least squares mean difference: -4; 95% confidence interval: -16.27 to 8.06; P for non-inferiority = 0.002). Other pharmacodynamic parameters were similar between the two ticagrelor doses and there were no differences in response to aspirin. Plasma levels of ticagrelor (398.29 ± 312.36 ng/mL vs. 579.57 ± 351.73 ng/mL, P = 0.006) and its active metabolite were significantly lower during treatment with ticagrelor 60 mg.
Although plasma concentrations were lower, ticagrelor 60 mg twice daily provided a similar magnitude of platelet inhibition compared with ticagrelor 90 mg twice daily among elderly patients undergoing PCI.</description><identifier>ISSN: 2055-6837</identifier><identifier>ISSN: 2055-6845</identifier><identifier>EISSN: 2055-6845</identifier><identifier>DOI: 10.1093/ehjcvp/pvae054</identifier><identifier>PMID: 39025785</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Acute Coronary Syndrome - blood ; Acute Coronary Syndrome - diagnosis ; Acute Coronary Syndrome - drug therapy ; Acute Coronary Syndrome - therapy ; Age Factors ; Aged ; Aged patients ; Aged, 80 and over ; Aggregation ; Aspirin - administration & dosage ; Aspirin - adverse effects ; Aspirin - pharmacokinetics ; Blood platelets ; Blood Platelets - drug effects ; Blood Platelets - metabolism ; Cardiac patients ; Care and treatment ; Coronary heart disease ; Cross-Over Studies ; Drug Administration Schedule ; Female ; Humans ; Male ; Metabolites ; Percutaneous Coronary Intervention - adverse effects ; Platelet Aggregation - drug effects ; Platelet Aggregation Inhibitors - administration & dosage ; Platelet Aggregation Inhibitors - adverse effects ; Platelet Aggregation Inhibitors - pharmacokinetics ; Platelet Function Tests ; Purinergic P2Y Receptor Antagonists - administration & dosage ; Purinergic P2Y Receptor Antagonists - adverse effects ; Purinergic P2Y Receptor Antagonists - pharmacokinetics ; Receptors, Purinergic P2Y12 - blood ; Receptors, Purinergic P2Y12 - drug effects ; Ticagrelor - administration & dosage ; Ticagrelor - adverse effects ; Ticagrelor - pharmacokinetics ; Time Factors ; Transluminal angioplasty ; Treatment Outcome</subject><ispartof>European heart journal. Cardiovascular pharmacotherapy, 2024-11, Vol.10 (7), p.578-587</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.</rights><rights>COPYRIGHT 2024 Oxford University Press</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c247t-d1f0e184e7999788d09c40c804492d32e8df5d41231334c2a8588e63e98659463</cites><orcidid>0000-0001-6897-9807 ; 0000-0002-3124-9912 ; 0000-0002-5170-517X ; 0000-0003-0565-7127</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39025785$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Piccolo, Raffaele</creatorcontrib><creatorcontrib>Simonetti, Fiorenzo</creatorcontrib><creatorcontrib>Avvedimento, Marisa</creatorcontrib><creatorcontrib>Cutillo, Maria</creatorcontrib><creatorcontrib>Canonico, Mario Enrico</creatorcontrib><creatorcontrib>Conti, Valeria</creatorcontrib><creatorcontrib>Gargiulo, Giuseppe</creatorcontrib><creatorcontrib>Paolillo, Roberta</creatorcontrib><creatorcontrib>Dal Piaz, Fabrizio</creatorcontrib><creatorcontrib>Filippelli, Amelia</creatorcontrib><creatorcontrib>Charlier, Bruno</creatorcontrib><creatorcontrib>Spinelli, Alessandra</creatorcontrib><creatorcontrib>Cristiano, Stefano</creatorcontrib><creatorcontrib>Cirillo, Plinio</creatorcontrib><creatorcontrib>Di Serafino, Luigi</creatorcontrib><creatorcontrib>Franzone, Anna</creatorcontrib><creatorcontrib>Esposito, Giovanni</creatorcontrib><title>Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial</title><title>European heart journal. Cardiovascular pharmacotherapy</title><addtitle>Eur Heart J Cardiovasc Pharmacother</addtitle><description>Although dual antiplatelet therapy with aspirin and a potent P2Y12 receptor inhibitor is currently recommended in patients with acute coronary syndrome (ACS), its use in elderly patients remains challenging. The aim of this trial is to evaluate the pharmacodynamic and pharmacokinetic profile of ticagrelor 60 vs. 90 mg twice daily among elderly patients (≥75 years) with ACS undergoing percutaneous coronary intervention (PCI).
PLINY The ELDER (NCT04739384) was a randomized, crossover trial testing the non-inferiority of a lower vs. standard dose of ticagrelor with respect to the primary endpoint of P2Y12 inhibition as determined by pre-dose P2Y12 reaction units (PRU) using the VerifyNow-P2Y12 (Accumetrics, San Diego, CA, USA). Other pharmacodynamic tests included light transmittance aggregometry, multiple electrode aggregometry, and response to aspirin. Plasma levels of ticagrelor and its active metabolite AR-C124910XX were also evaluated. A total of 50 patients (mean age 79.6 ± 4.0 years, females 44%) were included in the trial. Ticagrelor 60 mg was non-inferior to ticagrelor 90 mg according to VerifyNow-P2Y12 results (PRU 26.4 ± 32.1 vs. 30.4 ± 39.0; least squares mean difference: -4; 95% confidence interval: -16.27 to 8.06; P for non-inferiority = 0.002). Other pharmacodynamic parameters were similar between the two ticagrelor doses and there were no differences in response to aspirin. Plasma levels of ticagrelor (398.29 ± 312.36 ng/mL vs. 579.57 ± 351.73 ng/mL, P = 0.006) and its active metabolite were significantly lower during treatment with ticagrelor 60 mg.
Although plasma concentrations were lower, ticagrelor 60 mg twice daily provided a similar magnitude of platelet inhibition compared with ticagrelor 90 mg twice daily among elderly patients undergoing PCI.</description><subject>Acute Coronary Syndrome - blood</subject><subject>Acute Coronary Syndrome - diagnosis</subject><subject>Acute Coronary Syndrome - drug therapy</subject><subject>Acute Coronary Syndrome - therapy</subject><subject>Age Factors</subject><subject>Aged</subject><subject>Aged patients</subject><subject>Aged, 80 and over</subject><subject>Aggregation</subject><subject>Aspirin - administration & dosage</subject><subject>Aspirin - adverse effects</subject><subject>Aspirin - pharmacokinetics</subject><subject>Blood platelets</subject><subject>Blood Platelets - drug effects</subject><subject>Blood Platelets - metabolism</subject><subject>Cardiac patients</subject><subject>Care and treatment</subject><subject>Coronary heart disease</subject><subject>Cross-Over Studies</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Metabolites</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Platelet Aggregation - drug effects</subject><subject>Platelet Aggregation Inhibitors - administration & dosage</subject><subject>Platelet Aggregation Inhibitors - adverse effects</subject><subject>Platelet Aggregation Inhibitors - pharmacokinetics</subject><subject>Platelet Function Tests</subject><subject>Purinergic P2Y Receptor Antagonists - administration & dosage</subject><subject>Purinergic P2Y Receptor Antagonists - adverse effects</subject><subject>Purinergic P2Y Receptor Antagonists - pharmacokinetics</subject><subject>Receptors, Purinergic P2Y12 - blood</subject><subject>Receptors, Purinergic P2Y12 - drug effects</subject><subject>Ticagrelor - administration & dosage</subject><subject>Ticagrelor - adverse effects</subject><subject>Ticagrelor - pharmacokinetics</subject><subject>Time Factors</subject><subject>Transluminal angioplasty</subject><subject>Treatment Outcome</subject><issn>2055-6837</issn><issn>2055-6845</issn><issn>2055-6845</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkc1rGzEQxUVoqU2aa49BkEsPsa3PXak3Y9ImYEih6bEIVZrdyOyuttLa4Pz1WddOTmYOMzx-bxjmIfSFkjklmi_geeN2_aLfWSBSXKApI1LOCiXkh_eZlxN0lfOGEEILVTDFP6EJ14TJUskp-vMUnK0TNDHhguBdnmNNcFvj0GFoPKRmj5erX7i3Q4BuyHjbjWIdQ1fjn6uHb9jiZDsf2_AC_ha7FHOOO0h4SME2n9HHyjYZrk79Ev3-fve0up-tH388rJbrmWOiHGaeVgSoElBqrUulPNFOEKeIEJp5zkD5SnpBGaecC8eskkpBwUGrQmpR8Ev09bi3T_HfFvJg2pAdNI3tIG6z4USxgpVM8hG9OaK1bcCEropDsu6Am6WipeRay8PC-RlqLA9tcLGDKoz6OcP_DySoTJ9Ca9PeUGIOYZljWOYU1mi4Pp28_duCf8ffouGvE8-N4g</recordid><startdate>20241106</startdate><enddate>20241106</enddate><creator>Piccolo, Raffaele</creator><creator>Simonetti, Fiorenzo</creator><creator>Avvedimento, Marisa</creator><creator>Cutillo, Maria</creator><creator>Canonico, Mario Enrico</creator><creator>Conti, Valeria</creator><creator>Gargiulo, Giuseppe</creator><creator>Paolillo, Roberta</creator><creator>Dal Piaz, Fabrizio</creator><creator>Filippelli, Amelia</creator><creator>Charlier, Bruno</creator><creator>Spinelli, Alessandra</creator><creator>Cristiano, Stefano</creator><creator>Cirillo, Plinio</creator><creator>Di Serafino, Luigi</creator><creator>Franzone, Anna</creator><creator>Esposito, Giovanni</creator><general>Oxford University Press</general><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>7X8</scope><orcidid>https://orcid.org/0000-0001-6897-9807</orcidid><orcidid>https://orcid.org/0000-0002-3124-9912</orcidid><orcidid>https://orcid.org/0000-0002-5170-517X</orcidid><orcidid>https://orcid.org/0000-0003-0565-7127</orcidid></search><sort><creationdate>20241106</creationdate><title>Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial</title><author>Piccolo, Raffaele ; Simonetti, Fiorenzo ; Avvedimento, Marisa ; Cutillo, Maria ; Canonico, Mario Enrico ; Conti, Valeria ; Gargiulo, Giuseppe ; Paolillo, Roberta ; Dal Piaz, Fabrizio ; Filippelli, Amelia ; Charlier, Bruno ; Spinelli, Alessandra ; Cristiano, Stefano ; Cirillo, Plinio ; Di Serafino, Luigi ; Franzone, Anna ; Esposito, Giovanni</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c247t-d1f0e184e7999788d09c40c804492d32e8df5d41231334c2a8588e63e98659463</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Acute Coronary Syndrome - blood</topic><topic>Acute Coronary Syndrome - diagnosis</topic><topic>Acute Coronary Syndrome - drug therapy</topic><topic>Acute Coronary Syndrome - therapy</topic><topic>Age Factors</topic><topic>Aged</topic><topic>Aged patients</topic><topic>Aged, 80 and over</topic><topic>Aggregation</topic><topic>Aspirin - administration & dosage</topic><topic>Aspirin - adverse effects</topic><topic>Aspirin - pharmacokinetics</topic><topic>Blood platelets</topic><topic>Blood Platelets - drug effects</topic><topic>Blood Platelets - metabolism</topic><topic>Cardiac patients</topic><topic>Care and treatment</topic><topic>Coronary heart disease</topic><topic>Cross-Over Studies</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Metabolites</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Platelet Aggregation - drug effects</topic><topic>Platelet Aggregation Inhibitors - administration & dosage</topic><topic>Platelet Aggregation Inhibitors - adverse effects</topic><topic>Platelet Aggregation Inhibitors - pharmacokinetics</topic><topic>Platelet Function Tests</topic><topic>Purinergic P2Y Receptor Antagonists - administration & dosage</topic><topic>Purinergic P2Y Receptor Antagonists - adverse effects</topic><topic>Purinergic P2Y Receptor Antagonists - pharmacokinetics</topic><topic>Receptors, Purinergic P2Y12 - blood</topic><topic>Receptors, Purinergic P2Y12 - drug effects</topic><topic>Ticagrelor - administration & dosage</topic><topic>Ticagrelor - adverse effects</topic><topic>Ticagrelor - pharmacokinetics</topic><topic>Time Factors</topic><topic>Transluminal angioplasty</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Piccolo, Raffaele</creatorcontrib><creatorcontrib>Simonetti, Fiorenzo</creatorcontrib><creatorcontrib>Avvedimento, Marisa</creatorcontrib><creatorcontrib>Cutillo, Maria</creatorcontrib><creatorcontrib>Canonico, Mario Enrico</creatorcontrib><creatorcontrib>Conti, Valeria</creatorcontrib><creatorcontrib>Gargiulo, Giuseppe</creatorcontrib><creatorcontrib>Paolillo, Roberta</creatorcontrib><creatorcontrib>Dal Piaz, Fabrizio</creatorcontrib><creatorcontrib>Filippelli, Amelia</creatorcontrib><creatorcontrib>Charlier, Bruno</creatorcontrib><creatorcontrib>Spinelli, Alessandra</creatorcontrib><creatorcontrib>Cristiano, Stefano</creatorcontrib><creatorcontrib>Cirillo, Plinio</creatorcontrib><creatorcontrib>Di Serafino, Luigi</creatorcontrib><creatorcontrib>Franzone, Anna</creatorcontrib><creatorcontrib>Esposito, Giovanni</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European heart journal. Cardiovascular pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Piccolo, Raffaele</au><au>Simonetti, Fiorenzo</au><au>Avvedimento, Marisa</au><au>Cutillo, Maria</au><au>Canonico, Mario Enrico</au><au>Conti, Valeria</au><au>Gargiulo, Giuseppe</au><au>Paolillo, Roberta</au><au>Dal Piaz, Fabrizio</au><au>Filippelli, Amelia</au><au>Charlier, Bruno</au><au>Spinelli, Alessandra</au><au>Cristiano, Stefano</au><au>Cirillo, Plinio</au><au>Di Serafino, Luigi</au><au>Franzone, Anna</au><au>Esposito, Giovanni</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial</atitle><jtitle>European heart journal. Cardiovascular pharmacotherapy</jtitle><addtitle>Eur Heart J Cardiovasc Pharmacother</addtitle><date>2024-11-06</date><risdate>2024</risdate><volume>10</volume><issue>7</issue><spage>578</spage><epage>587</epage><pages>578-587</pages><issn>2055-6837</issn><issn>2055-6845</issn><eissn>2055-6845</eissn><abstract>Although dual antiplatelet therapy with aspirin and a potent P2Y12 receptor inhibitor is currently recommended in patients with acute coronary syndrome (ACS), its use in elderly patients remains challenging. The aim of this trial is to evaluate the pharmacodynamic and pharmacokinetic profile of ticagrelor 60 vs. 90 mg twice daily among elderly patients (≥75 years) with ACS undergoing percutaneous coronary intervention (PCI).
PLINY The ELDER (NCT04739384) was a randomized, crossover trial testing the non-inferiority of a lower vs. standard dose of ticagrelor with respect to the primary endpoint of P2Y12 inhibition as determined by pre-dose P2Y12 reaction units (PRU) using the VerifyNow-P2Y12 (Accumetrics, San Diego, CA, USA). Other pharmacodynamic tests included light transmittance aggregometry, multiple electrode aggregometry, and response to aspirin. Plasma levels of ticagrelor and its active metabolite AR-C124910XX were also evaluated. A total of 50 patients (mean age 79.6 ± 4.0 years, females 44%) were included in the trial. Ticagrelor 60 mg was non-inferior to ticagrelor 90 mg according to VerifyNow-P2Y12 results (PRU 26.4 ± 32.1 vs. 30.4 ± 39.0; least squares mean difference: -4; 95% confidence interval: -16.27 to 8.06; P for non-inferiority = 0.002). Other pharmacodynamic parameters were similar between the two ticagrelor doses and there were no differences in response to aspirin. Plasma levels of ticagrelor (398.29 ± 312.36 ng/mL vs. 579.57 ± 351.73 ng/mL, P = 0.006) and its active metabolite were significantly lower during treatment with ticagrelor 60 mg.
Although plasma concentrations were lower, ticagrelor 60 mg twice daily provided a similar magnitude of platelet inhibition compared with ticagrelor 90 mg twice daily among elderly patients undergoing PCI.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>39025785</pmid><doi>10.1093/ehjcvp/pvae054</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6897-9807</orcidid><orcidid>https://orcid.org/0000-0002-3124-9912</orcidid><orcidid>https://orcid.org/0000-0002-5170-517X</orcidid><orcidid>https://orcid.org/0000-0003-0565-7127</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | European heart journal. Cardiovascular pharmacotherapy, 2024-11, Vol.10 (7), p.578-587 |
| issn | 2055-6837 2055-6845 2055-6845 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Acute Coronary Syndrome - blood Acute Coronary Syndrome - diagnosis Acute Coronary Syndrome - drug therapy Acute Coronary Syndrome - therapy Age Factors Aged Aged patients Aged, 80 and over Aggregation Aspirin - administration & dosage Aspirin - adverse effects Aspirin - pharmacokinetics Blood platelets Blood Platelets - drug effects Blood Platelets - metabolism Cardiac patients Care and treatment Coronary heart disease Cross-Over Studies Drug Administration Schedule Female Humans Male Metabolites Percutaneous Coronary Intervention - adverse effects Platelet Aggregation - drug effects Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - pharmacokinetics Platelet Function Tests Purinergic P2Y Receptor Antagonists - administration & dosage Purinergic P2Y Receptor Antagonists - adverse effects Purinergic P2Y Receptor Antagonists - pharmacokinetics Receptors, Purinergic P2Y12 - blood Receptors, Purinergic P2Y12 - drug effects Ticagrelor - administration & dosage Ticagrelor - adverse effects Ticagrelor - pharmacokinetics Time Factors Transluminal angioplasty Treatment Outcome |
| title | Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial |
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