NCT00821834已完成3 期
A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to Which Percutaneous Coronary Intervention is Being Planned - With Extended Treatment of Clopidogrel 75 mg Once Daily for 40 Weeks in a Patients' Subset
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,003
- 试验地点
- 1
- 主要终点
- Time from randomization to first safety events of interest
研究概览
简要总结
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.
Secondary objectives:
- To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.
- To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.
- To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;
- To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.
详细描述
The study consisted of two periods:
- a double blind treatment period of 12 weeks followed by,
- an open label clopidogrel treatment period in a subset of patients.
All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable Angina / Old Myocardial Infarction patients who met all of the following criteria:
- •Myocardial ischemic finding was proven within 2 months before randomization,
- •Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
- •PCI was being planned.
排除标准
- •Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
- •3-vessel coronary artery disease with significant lesions in each vessel,
- •Planned PCI associated with 6 or more stent placements,
- •Not less than 50% stenosis of the left main coronary artery,
- •Chronic total occlusion (CTO),
- •Saphenous vein graft (SVG).
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Clopidogrel
Experimental
Patients received:
- clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose,
- ticlopidine matching placebo twice daily.
干预措施: clopidogrel (SR25990) (Drug)
Clopidogrel
Experimental
Patients received:
- clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose,
- ticlopidine matching placebo twice daily.
干预措施: Placebo (Drug)
Ticlopidine
Active Comparator
Patients received:
- ticlopidine 100 mg twice daily,
- clopidogrel matching placebo once daily.
干预措施: ticlopidine (Drug)
Ticlopidine
Active Comparator
Patients received:
- ticlopidine 100 mg twice daily,
- clopidogrel matching placebo once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Time from randomization to first safety events of interest
时间窗: 12 Weeks (duble blind treatment period)
Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.
次要结局
- Time from randomization to first Major Adverse Cardiac Events (MACE)(12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period))
- Time from randomization to first bleeding events(12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period))
- Time from randomization to first Adverse Events / Adverse Drug Reactions(12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period))
- Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)(12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period))
研究者
研究点 (1)
Loading locations...
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