EUCTR2014-002004-24-HR进行中（未招募）1 期
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. (Augustus)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed Written Informed Consent
- •a) Subjects will be required to provide a written informed consent.
- •2. Target Population
- •a) Males and females 18 years of age (or age of majority) or older 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.
- •b) Must have had an acute coronary syndrome (ST-elevation myocardial infarction
- •[STEMI], non-ST-elevation myocardial infarction [NSTEMI], or unstable angina), within
- •the prior 14 days
- •c) Planned use of an approved P2Y12 inhibitor for at least 6 months.3. Subject Re-enrollment:
- •a) This study does permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (screen failure).
- •4. Age and Reproductive Status
- •a) Women of childbearing potential (WOCBP) must have a negative serum or urine
- •pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within
- •24 hours prior to the start of study drug.
- •b) Women must not be breastfeeding
- •c) WOCBP must agree to use effective contraception for the duration of treatment with study drugs plus
- •i. 33 days for patients on apixaban
- •ii. 40 days for patients on warfarin
- •d) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section.
- •Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1978
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2622
排除标准
- •- Conditions other than atrial fibrillation that require chronic anticoagulation (eg, prosthetic mechanical heart valve)
- •- Severe renal insufficiency (serum creatinine > 2.5 [221 micromol/L] or a calculated creatinine clearance < 30 mL/min
- •- Patients with any history of intracranial hemorrhage
- •- Any contraindications to warfarin, apixaban, to intended P2Y12 inhibitors or to aspirin
- •- Patients who have or will undergo coronary arterial bypass graft (CABG) for their index
- •- Patients with known ongoing bleeding
- •- Patients with known coagulopathies
研究者
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