Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- ADP- induced platelet inhibition rate
研究概览
简要总结
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups:
Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is scheduled to undergo non-urgent PCI
- •The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol
- •The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC
排除标准
- •Estimated or measured weight < 55 kg
- •Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI
- •Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- •Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled
- •Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI
- •Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
- •Anemia with hemoglobin level < 10 g/dL
- •Thrombocytopenia (platelet count < 100,000/mm3)
- •ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic dysfunction
- •Facial or head trauma within the last 30 days
- •Intraocular hemorrhage within the last 30 days
- •Gastrointestinal bleeding within the last 30 days
- •Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation
- •Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast media
- •Participation in any investigational drug study within 30 days prior to enrollment.
研究组 & 干预措施
Domestic Clopidogrel 300mg
Domestic Clopidogrel 300mg
干预措施: Clopidogrel (Drug)
Domestic Clopidogrel 600mg
Domestic Clopidogrel 600mg
干预措施: Clopidogrel (Drug)
Imported Clopidogrel 300mg
Imported Clopidogrel 300mg
干预措施: Clopidogrel (Drug)
Imported Clopidogrel 600mg
Imported Clopidogrel 600mg
干预措施: Clopidogrel (Drug)
结局指标
主要结局
ADP- induced platelet inhibition rate
时间窗: 30 days after the loading dose
次要结局
- R value (min)(2 hours after the loading dose)