A Randomized Controlled Trial of Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy and Oral Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: OVER-TIME
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Composite of cardiovascular death, recurrent MI and repeated revascularization
研究概览
简要总结
The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear.
OVER-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. The investigators aim to enroll 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.
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.
详细描述
Coronary artery ectasia (CAE) is defined as a segmental or diffuse abnormal dilatation that exceeds more than 1.5 times the diameter of a normal adjacent coronary segment. The prevalence of CAE ranges from 0.3 to 4.9% and atherosclerosis is believed to be the most common etiology. According to angiographic findings, blood flow might be altered by the inappropriate dilatation in the affected arteries resulting in platelet activation and thrombus formation. Also, the presence of CAE has been related with elevated inflammatory markers and plasma soluble adhesion molecules which are an important component of vascular aneurysm formation.
Patients with MI and CAE have an increased risk of major adverse cardiovascular events (MACE) compared with those without CAE. However, it is unclear which is the optimal antithrombotic therapy for the prevention of recurrent ischemic events in patients with CAE after acute coronary syndrome (ACS)
OVER-TIME will be the first randomized controlled trial to provide insight into the safety and efficacy of different antithrombotic strategies in patients with CAE after an ACS event.
OVER- TIME is an investigator initiated, exploratory, open label, single center, randomized clinical trial comparing dual antiplatelet therapy (acetyl-salicylic acid plus a P2Y12 inhibitor) versus the combination of antiplatelet monotherapy (P2Y12 inhibitor) plus low dose anticoagulant (rivaroxaban, 15mg oral dose) for prevention of recurrent ischemic events in patients with established CAE and ACS. The trial protocol received local research and ethics committee approval and complies with the principles of the Declaration of Helsinki. Written informed consent was obtained from all patients prior to randomization.
Study patients are aged 18 or more, hospitalized with the diagnosis of ACS (NSTEMI & STEMI) undergoing coronary angiogram showing CAE in the infarction culprit artery. CAE is defined as segmental or diffuse abnormal dilatation that exceeds more than 1.5 times the diameter of a normal adjacent coronary segment. The definition of a CAE case will be based on the opinion of two independent interventional cardiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities.
- •Hospitalized male or female aged >18 years.
- •First event of ACS (including both, ST- Segment Elevation or Non- ST Elevation Myocardial Infarction) with high sensitivity troponin T levels exceeding 99th percentile or segmental motion abnormalities by echocardiography.
- •Angiographic evidence of CAE involving the infarction culprit artery.
- •Hospital length of stay >24 hours.
- •Percutaneous revascularization or medical treatment according to the treating physician criteria.
排除标准
- •Indication for temporary or permanent anticoagulation.
- •Relative or absolute contraindications to receive anticoagulation.
- •Chronic kidney disease (CKD) KDIGO > III or GFR <30 ml/min/1.73 m2
- •Angiographic evidence of coronary aneurysms (saccular or fusiform)
- •Patients undergoing coronary artery bypass graft (CABG).
- •Left ventricular ejection fraction <40%.
- •History of major bleeding events.
- •Pregnant women.
研究组 & 干预措施
Dual antiplatelet therapy
Acetyl salicylic acid, 100mg once a day + clopidogrel 75mg, once a day.
干预措施: Acetylsalicylic acid 100mg (Drug)
Dual antiplatelet therapy
Acetyl salicylic acid, 100mg once a day + clopidogrel 75mg, once a day.
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
Antiplatelet monotherapy + low dose anticoagulant
Clopidogrel 75mg + Rivaroxaban 75mg
干预措施: Rivaroxaban 15 MG (Drug)
Antiplatelet monotherapy + low dose anticoagulant
Clopidogrel 75mg + Rivaroxaban 75mg
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
结局指标
主要结局
Composite of cardiovascular death, recurrent MI and repeated revascularization
时间窗: 1 year.
Main efficacy combined outcome of cardiovascular death, recurrent MI and repeated revascularization
Composite of minor and major bleeding events.
时间窗: 1 year
Main safety combined outcome of minor and major events, measured by BARC scale.
次要结局
- Clot lysis time by turbidimetry(6 months)
- Net clinical benefit composite endpoint, including cardiovascular death, recurrent MI, repeated revascularization and minor/major bleeding(1 year)
研究者
Diego Araiza-Garaygordobil
Principal investigator
Instituto Nacional de Cardiologia Ignacio Chavez