A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
研究概览
简要总结
This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
- •Are between the ages of 18 and 85 years.
- •Willing and able to sign informed consent.
排除标准
- •Have overt ST-segment elevation myocardial infarction (STEMI).
- •Have cardiogenic shock.
- •Have refractory ventricular arrhythmias.
- •Have New York Heart Association (NYHA) Class IV congestive heart failure.
- •Have severe and uncontrolled hypertension.
- •Have active internal bleeding or history of bleeding diathesis.
- •Have an increased risk of bleeding.
- •Have history of cerebrovascular accidents.
- •Have certain abnormal blood level values.
- •Are currently receiving chemotherapy or radiation therapy.
研究组 & 干预措施
Prasugrel
Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days.
干预措施: Prasugrel (Drug)
Clopidogrel
Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
时间窗: 14 days after maintenance dose (MD)
Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).
次要结局
- MPA to 5 μM ADP(14 days after maintenance dose (MD))
- Mean Residual Platelet Aggregation (RPA) to 20 µM ADP(14 days after maintenance dose (MD))
- Mean Residual Platelet Aggregation (RPA) to 5 µM ADP(14 days after maintenance dose (MD))
- Inhibition Platelet Aggregation (IPA) to 20 μM ADP(14 days after maintenance dose (MD))
- Inhibition Platelet Aggregation (IPA) to 5 μM ADP(14 days after maintenance dose (MD))
- Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP(14 days after maintenance dose (MD))
- Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP(14 days after maintenance dose (MD))
- Platelet Reactivity Index (PRI)(14 days after maintenance dose (MD))
- P2Y12 Reaction Units (PRU)(14 days after maintenance dose (MD))
- Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)(14 days after maintenance dose (MD))
- Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)(Baseline to 6-18 hrs post loading dose (LD))
- Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)(6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD))
- MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)(14 days after the first maintenance dose (MD))
- MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)(14 days after the second maintenance dose (MD))
- Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria(14 days after maintenance dose (MD))
- Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)(14 days after maintenance dose (MD))
- Correlation of MPA to 20 μM ADP and PRU(Baseline through 29 days of treatment)