A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12,944
- 主要终点
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization
研究概览
简要总结
The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.
The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.
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
- Triple (Participant, 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 at least 18 years old with current clinical manifestation of non-ST-segment-elevation myocardial infarction (heart attack) according to the following three criteria:
- •current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heart attack)
- •either of the following:
- •concurrent elevation of troponin I or T, or of creatine kinase - myocardial band (CK-MB) to a level above the upper limit of normal, OR
- •concurrent appropriate electrocardiographic evidence
- •any one (or more) of the following:
- •age >= 55 years
- •documented history of prior heart attack or coronary revascularization (eg, angioplasty [PCI], coronary artery replacement [CABG])
- •diabetes (documented use of insulin or oral hypoglycemic[s])
- •documented history of peripheral arterial disease
排除标准
- •history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor, or aneurysm
- •any bleeding disorder or abnormality
- •sustained severe hypertension or valvular heart disease
- •current or recent platelet count <100,000 mm^3
- •planned or ongoing treatment with a blood thinning medication
- •pregnancy
- •any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
研究组 & 干预措施
Placebo
Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
干预措施: Placebo (Drug)
Vorapaxar
Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
干预措施: Vorapaxar (Drug)
结局指标
主要结局
Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization
时间窗: Up to 2 years
The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with re-hospitalization (RIR), and/or urgent coronary revascularization (UCR). A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the primary composite efficacy endpoint within 2 years from randomization.
次要结局
- Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization(up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization(Up to 2 years)
- Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization(Up to 2 years)