Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Oral Anticoagulation in Patients with Acute Coronary Syndrome and Coronary Artery Ectasia: Design and Rationale of OVER-TIME Randomized Clinical Trial
IntroductionThe optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear.AimTo assess the efficacy and safety of antiplatelet plus anticoagulant therapy versus dual antiplatelet therapy in patients...
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| Veröffentlicht in: | High Blood Pressure & Cardiovascular Prevention 2022-09, Vol.29 (5), p.463-468 |
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| creator | Araiza-Garaygordobil, Diego Gopar-Nieto, Rodrigo Sierra-Lara Martínez, Daniel Belderrain-Morales, Nallely Sarabia-Chao, Vianney Alfaro-Ponce, Diana Laura Ontiveros-Mercado, Heriberto Mendoza-García, Salvador Altamirano-Castillo, Alfredo Martinez-Amezcua, Pablo Cabello-López, Alejandro Briseño-De la Cruz, Jose Luis Ruiz-Beltrán, Maximiliano Martínez-Ríos, Marco Antonio Piña-Reyna, Yigal Gonzalez-Pacheco, Hector Arias-Mendoza, Alexandra |
| description | IntroductionThe optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear.AimTo assess the efficacy and safety of antiplatelet plus anticoagulant therapy versus dual antiplatelet therapy in patients with acute coronary syndromes and coronary artery ectasia.MethodsOVER-TIME is an investigator initiated, exploratory, open label, single center, randomized clinical trial comparing dual antiplatelet therapy (acetyl-salicylic acid plus a P2Y12 inhibitor) with the combination of an antiplatelet monotherapy (a P2Y12 inhibitor) plus a low dose anticoagulant (rivaroxaban, 15mg oral dose) for the prevention of recurrent ischemic events among patients with CAE. We aim to enroll approximately 60 patients with CAE and acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care (dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to assess the efficacy of the regimen in prevention of major cardiovascular events and its security in bleeding events in acute coronary syndromes among patients with CAE.Expected results and conclusions: OVER-TIME is the first randomized controlled trial to assess different antithrombotic strategies in patients with CAE and acute coronary syndrome, and its results will offer preliminary data for the prevention of major cardiovascular events and bleeding events in this group of patients.Trial Registration NumberNCT05233124 (ClinicalTrials.gov), date of registration: February 10, 2022. |
| doi_str_mv | 10.1007/s40292-022-00535-4 |
| format | Article |
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We aim to enroll approximately 60 patients with CAE and acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care (dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to assess the efficacy of the regimen in prevention of major cardiovascular events and its security in bleeding events in acute coronary syndromes among patients with CAE.Expected results and conclusions: OVER-TIME is the first randomized controlled trial to assess different antithrombotic strategies in patients with CAE and acute coronary syndrome, and its results will offer preliminary data for the prevention of major cardiovascular events and bleeding events in this group of patients.Trial Registration NumberNCT05233124 (ClinicalTrials.gov), date of registration: February 10, 2022.</description><identifier>ISSN: 1179-1985</identifier><identifier>ISSN: 1120-9879</identifier><identifier>EISSN: 1179-1985</identifier><identifier>DOI: 10.1007/s40292-022-00535-4</identifier><language>eng</language><publisher>Auckland: Springer Nature B.V</publisher><subject>Acute coronary syndromes ; Aneurysms ; Anticoagulants ; Biomarkers ; Cardiovascular disease ; Clinical outcomes ; Clinical trials ; Disease prevention ; Genotype & phenotype ; Polypharmacy ; Veins & arteries</subject><ispartof>High Blood Pressure & Cardiovascular Prevention, 2022-09, Vol.29 (5), p.463-468</ispartof><rights>Italian Society of Hypertension 2022. 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We aim to enroll approximately 60 patients with CAE and acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care (dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to assess the efficacy of the regimen in prevention of major cardiovascular events and its security in bleeding events in acute coronary syndromes among patients with CAE.Expected results and conclusions: OVER-TIME is the first randomized controlled trial to assess different antithrombotic strategies in patients with CAE and acute coronary syndrome, and its results will offer preliminary data for the prevention of major cardiovascular events and bleeding events in this group of patients.Trial Registration NumberNCT05233124 (ClinicalTrials.gov), date of registration: February 10, 2022.</description><subject>Acute coronary syndromes</subject><subject>Aneurysms</subject><subject>Anticoagulants</subject><subject>Biomarkers</subject><subject>Cardiovascular disease</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Disease prevention</subject><subject>Genotype & phenotype</subject><subject>Polypharmacy</subject><subject>Veins & 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artery ectasia.MethodsOVER-TIME is an investigator initiated, exploratory, open label, single center, randomized clinical trial comparing dual antiplatelet therapy (acetyl-salicylic acid plus a P2Y12 inhibitor) with the combination of an antiplatelet monotherapy (a P2Y12 inhibitor) plus a low dose anticoagulant (rivaroxaban, 15mg oral dose) for the prevention of recurrent ischemic events among patients with CAE. We aim to enroll approximately 60 patients with CAE and acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care (dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to assess the efficacy of the regimen in prevention of major cardiovascular events and its security in bleeding events in acute coronary syndromes among patients with CAE.Expected results and conclusions: OVER-TIME is the first randomized controlled trial to assess different antithrombotic strategies in patients with CAE and acute coronary syndrome, and its results will offer preliminary data for the prevention of major cardiovascular events and bleeding events in this group of patients.Trial Registration NumberNCT05233124 (ClinicalTrials.gov), date of registration: February 10, 2022.</abstract><cop>Auckland</cop><pub>Springer Nature B.V</pub><doi>10.1007/s40292-022-00535-4</doi><tpages>6</tpages></addata></record> |
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| subjects | Acute coronary syndromes Aneurysms Anticoagulants Biomarkers Cardiovascular disease Clinical outcomes Clinical trials Disease prevention Genotype & phenotype Polypharmacy Veins & arteries |
| title | Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Oral Anticoagulation in Patients with Acute Coronary Syndrome and Coronary Artery Ectasia: Design and Rationale of OVER-TIME Randomized Clinical Trial |
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