Safety and Efficacy of Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After Drug-coated Balloons for Coronary Small Vessel Disease: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation, Single-center Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
The present study is aimed to determine the safety and efficacy of Ticagrelor single antiplatelet therapy (SAPT) in patients with primary coronary small vessel disease at high risk of bleeding after drug coated balloon (DCB) therapy.
详细描述
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 234 patients with high-risk bleeding and primary coronary small vessel disease after DCB enrolled in our research, randomly dividing into an experimental group (Ticagrelor SAPT, 90mg BID * 1 month, followed by 60mg BID, n=117) and a control group (DAPT, aspirin 100mg QD+clopidogrel 75mg QD * 1 month, followed by clopidogrel 75mg QD, n=117).The primary endpoint is 12 months of Major adverse cardiovascular events (MACE), including death, myocardial infarction, stroke, and target vessel revascularization. The key secondary endpoint is MACE at 1 month. The safety endpoint is BARC bleeding at all levels. Follow up will be conducted at 1 month and 12 months, and platelet inhibition rate will be measured.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHD patients aged 18-80 with clear indications for PCI, regardless of gender;
- •Received DCB treatment with only one small coronary artery (diameter 2.0-2.75mm);
- •High risk of bleeding (ARC high risk criteria for bleeding): Meets at least one main criterion (use of anticoagulants, liver dysfunction, tumors, history of gastrointestinal bleeding, history of peptic ulcers, creatinine clearance rate<30mL/min, hemoglobin<11g/L, platelet count<100 × 109/L) or 2 sub criteria (age ≥ 75 years old, creatinine clearance rate<60mL/min, history of stroke/TIA, hemoglobin 11-12.9g/L for males or 11-11.9g/L for females);
- •Willing to participate in trials and complete follow-up;
- •Signed an informed consent form approved by the Ethics Committee;
排除标准
- •Simultaneously or plan to perform other coronary PCI procedures in batches, including stent implantation, DCB treatment for non-small vessel lesions, and DCB treatment for in stent restenosis lesions.
- •High ischemic risk: a. ACS within 1 year; b. Perform stent implantation or CABG surgery within 1 year; c. Double or multi vessel lesions rearched incomplete revascularization; d. In addition to the target lesions for DCB intervention, there are other stenosis ≥ 90%, regardless of whether PCI is planned or not;
- •Anticoagulant drugs are required for atrial fibrillation/deep vein thrombosis (including pulmonary embolism)/mechanical valve implantation;
- •Cardiomyopathy (HCM/DCM/RCM);
- •Severe ventricular arrhythmias requires radiofrequency ablation or ICD implantation;
- •Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease);
- •Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients;
- •Blood system diseases with coagulation disorders such as thrombocytopenia, leukemia, and hemophilia;
- •Thrombotic diseases such as antiphospholipid antibody syndrome;
- •Cognitive impairment;
- •Not willing to participate in experiments or cooperate with follow-up;
研究组 & 干预措施
SAPT
Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID
干预措施: Ticagrelor (Drug)
DAPT
Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD
干预措施: Clopidogrel (Drug)
DAPT
Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD
干预措施: Aspirin (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 12 months after randomization
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
次要结局
- Major Adverse Cardiovascular Events (Key secondary endpoint)(1 month after randomization)
- Platelet inhibition rate (thromboelastogram)(12 months after randomization)
- Rate of patients taking medicine as prescribed(12 months after randomization)
- Rate of patients discontinued medication due to bleeding(12 months after randomization)
研究者
Qian Haiyan
MD, PhD
Fu Wai Hospital, Beijing, China