Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)
研究概览
简要总结
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.
详细描述
The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Participants who are planned to undergo PCI will be the target participants.
- •A: Positive biomarkers [Elevated troponin I or creatinine kinase MB isozyme greater than the site's upper limit of normal (ULN)] at or before registration
- •B: Electrocardiogram (ECG) changes: ST segment depression >= 0.1 mV (>=1 mm), or transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2 contiguous leads
- •Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
- •Women of child-bearing potential (all postmenarchal women who are <1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.
排除标准
- •Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
- •Any serious illness or any condition that the investigator feels would pose a significant hazard to the participant if investigational therapy were initiated
- •known hypersensitivity to any component of the current investigational product;
- •Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment
- •Member of the staff personnel directly involved with this study;
- •Family member of the investigational study staff;
- •History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
- •History of a hemorrhagic stroke at any time
- •Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;
- •Major surgery within 2 weeks prior to enrollment
- •Known platelet count <100,000/mm^3
- •Uncontrolled cardiac arrhythmia;
- •Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease;
- •Active or chronic hepatobiliary or hepatic disease, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) activity more than two times greater than the upper limit of the laboratory reference range
- •Anticipated staged PCI
- •Concurrent or anticipated treatment with warfarin, factor Xa inhibitor, direct thrombin inhibitor, or antiplatelet agents except aspirin and ticlopidine after enrollment
- •Anticipated intracoronary brachytherapy
研究组 & 干预措施
Vorapaxar 20 mg/1 mg
Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Vorapaxar (Drug)
Vorapaxar 20 mg/1 mg
Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Aspirin (Drug)
Vorapaxar 20 mg/1 mg
Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Clopidogrel (Drug)
Vorapaxar 20 mg/2.5 mg
Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Vorapaxar (Drug)
Vorapaxar 20 mg/2.5 mg
Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Aspirin (Drug)
Vorapaxar 20 mg/2.5 mg
Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Clopidogrel (Drug)
Vorapaxar 40 mg/1 mg
Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Vorapaxar (Drug)
Vorapaxar 40 mg/1 mg
Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Aspirin (Drug)
Vorapaxar 40 mg/1 mg
Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Clopidogrel (Drug)
Vorapaxar 40 mg/2.5 mg
Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Vorapaxar (Drug)
Vorapaxar 40 mg/2.5 mg
Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Aspirin (Drug)
Vorapaxar 40 mg/2.5 mg
Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Clopidogrel (Drug)
Placebo
Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Placebo (Drug)
Placebo
Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Aspirin (Drug)
Placebo
Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)
时间窗: Up to Day 60
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
次要结局
- Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI(Up to Day 121)
- Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge(Up to Day 121)
- Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI(Up to Day 121)
- Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI(Up to Day 60)
- Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit(Baseline, Day 30, Day 60, Day 74, Day 90, Day 121)
- Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit(Baseline, Day 30, Day 60)
- Mean CD40 Ligand Levels Among Participants Who Underwent PCI(Baseline, Day 30, Day 60)
- Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI(Baseline, Day 30, Day 60)
- Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI(Up to Day 60)
- Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events(Up to 10 Hours Post-CABG)
- Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion(Up to Day 60)
- Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization(Up to Day 30)
- Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI(Baseline Up To Day 60)
- Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI(Baseline Up To Day 60)
- Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events(Baseline Up To Day 60)