Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery: A Prospective, Multicenter, Randomized Study Comparing Two Durations of Dual Antiplatelet Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 660
- 主要终点
- bleeding events at 12 months
研究概览
简要总结
Coronary arteries are in charge of oxygen supply for the myocardium. When coronary arteries develop stenosis the coronary blood flow (i.e. oxygen flow) is reduced. Chronic total occlusion (CTO) is the extreme evolution of a coronary stenosis, which ends up to a total vessel closure.
Percutaneous coronary intervention (PCI) is the main treatment for chronic occlusions. The principle of this treatment is to implant a stent covering the whole segment of occlusion and allowing the blood to perfuse the myocardium antegradely and not retrogradely via the collateral(s). This angioplasty and stent implantation requires a dual antiplatelet therapy (aspirin associated with clopidogrel) to prevent a new thrombosis within the newly placed coronary stent.
Following the development of coronary stent (and particularly drug eluting coronary stent) new thrombosis within the implanted coronary scaffold have emerged. Dual antiplatelet therapy (DAPT) (compared to single antiplatelet therapy or anticoagulant) and initially prolonged DAPT (12 months) has offered a preventive treatment for stent thrombosis after PCI.
PCI treatment for CTOs continues to increase in France and around the world, while no dedicated study has been proposed so far regarding DAPT duration. Therefore, the general European recommendations for DAPT in chronic coronary syndrome management guidelines should be applied even though the CTO poses specific technical challenges (long and multiple stenting length for example). Even if 6 months DAPT is recommended as routine duration in chronic coronary syndrome (CCS), longer DAPT (12 months) is possible in this setting. However, the optimal duration of DAPT is not clearly demonstrated on an individual basis and each physician must adapt the DAPT duration for each single patient. A so called "ischemic / bleeding balance "guides the duration of DAPT.
This study would be the first randomized protocol to clarify the efficacy and safety of a shorter DAPT duration in the specific context of CTO PCI. It is conceivable that the technical advances which have made it possible to reduce the duration of DAPT to up to 1 month, in the cases of patients at high risk of bleeding for example, could be applicable to CTO PCI. Therefore, reducing the DAPT to 1 month, in the setting of CTO PCI, could reduce the haemorrhagic risk which should be proportional to the duration of the DAPT. Moreover, the invesitgators will evaluate the safety of short DAPT in terms of ischemic events during follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent a successful coronary stent implantation for chronic coronary occlusion, eligible for long-term aspirin therapy and requiring a dual antiplatelet therapy
- •Affiliated to Social Security system.
- •Signature of informed consent.
- •Age > 18 years old.
排除标准
- •Dual antiplatelet therapy contra-indication
- •Patient with hypersensitivity to aspirin (or any of its excipients) and/or to any of the active substance or to any of the excipients of the investigational medical product used in this study (clopidogrel);
- •Patient with contraindication to aspirin and/or clopidogrel.
- •No coronary stent implanted
- •Age < 18years
- •Patient under guardianship
- •Pregnancy or breast feeding
- •Prasugrel or ticagrelor use
研究组 & 干预措施
Long dual Aspirin/Clopidogrel therapy
Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
干预措施: Percutaneous coronary intervention (Procedure)
Long dual Aspirin/Clopidogrel therapy
Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
干预措施: Long dual Aspirin/Clopidogrel therapy (Other)
Long dual Aspirin/Clopidogrel therapy
Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
干预措施: Follow-up visit at 1 month (Other)
Long dual Aspirin/Clopidogrel therapy
Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
干预措施: Follow-up visit at 6 months (Other)
Long dual Aspirin/Clopidogrel therapy
Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
干预措施: Follow-up visit at 12 months (Other)
Short dual Aspirin/Clopidogrel therapy
Patients will be treated with short dual antiplatelet aggregation for 1month
干预措施: Percutaneous coronary intervention (Procedure)
Short dual Aspirin/Clopidogrel therapy
Patients will be treated with short dual antiplatelet aggregation for 1month
干预措施: Short dual Aspirin/Clopidogrel therapy (Drug)
Short dual Aspirin/Clopidogrel therapy
Patients will be treated with short dual antiplatelet aggregation for 1month
干预措施: Follow-up visit at 1 month (Other)
结局指标
主要结局
bleeding events at 12 months
时间窗: 12 months
time-to-composite endpoint of bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) Classification (BARC2 to BARC5) during follow-up (12 months).
ischemic events at 12 months
时间窗: 12 months
time-to-composite endpoint of ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) will be recorded during follow-up (12 months).
次要结局
- Time-to-all cause death(12 months)
- Compliance to drug regimen at 1 month(1 month)
- Major adverse ischemic clinical events (MACE)(12 months)
- Time-to-bleeding(12 months)
- Compliance to drug regimen at 6 months(6 months)
- Compliance to drug regimen at 12 months(12 months)