An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,614
- 试验地点
- 93
- 主要终点
- The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
研究概览
简要总结
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.
详细描述
Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.
Masking:
Apixaban: Open label.
VKA: Open label.
Acetylsalicylic acid film coated tablet: Double Blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
- •Planned use of antiplatelet agents for at least 1 to 6 months
- •Males and Females ≥ 18 years of age
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
排除标准
- •Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- •Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
- •Patients with a history of intracranial hemorrhage
- •Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- •Patients with known ongoing bleeding and patients with known coagulopathies
- •Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin
研究组 & 干预措施
Apixaban
5 mg or 2.5 mg Apixaban tablets orally twice per day
干预措施: Apixaban (Drug)
Vitamin K Antagonist
VKA tablets orally once daily
干预措施: vitamin K antagonist (Drug)
Acetylsalicylic acid film coated tablet
81 mg Acetylsalicylic acid film coated tablet orally once daily
干预措施: Acetylsalicylic acid (Drug)
Placebo matching Acetylsalicylic acid film coated tablet
Placebo matching Acetylsalicylic acid film coated tablet once daily
干预措施: Acetylsalicylic acid placebo (Other)
结局指标
主要结局
The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
时间窗: Approximately 6 months
Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
时间窗: Approximately 6 months
Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo. N is the number of participants with aspirin or placebo. n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
次要结局
- Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA(Approximately 6 months)
- The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA(Approximately 6 months)
- The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin(Approximately 6 months)
- The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA(Approximately 6 months)
- The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin(Approximately 6 months)