EUCTR2008-008298-77-SK进行中（未招募）1 期
Apixaban for Prevention of Acute Ischemic Events - 2A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome - APPRAISE - 2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10,800
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) Age = 18 years
- •2) Written informed consent.
- •3) An acute coronary syndrome (ST-elevation or non-ST-elevation MI or UA) within 7 days characterized by:
- •a) symptoms of myocardial ischemia at rest lasting at least 10 minutes and either
- •b) elevation in cardiac biomarkers (troponin T or I or creatine kinase MB) above the local upper limit of normal)
- •c) dynamic ST-segment deviation (depression or elevation = 0.1 mV (1.0 mm)
- •4) Completion of parenteral anticoagulation therapy for the index ACS event.
- •5) Clinically stable, receiving standard of care for ACS, including single (aspirin or a P2Y12 antagonist such as clopidogrel) or dual (aspirin plus a P2Y12 antagonist such as clopidogrel) antiplatelet therapy, at the discretion of the treating physician.
- •6) Two or more of the following risk factors
- •a) Age = 65 years
- •b) Diabetes mellitus
- •c) Prior myocardial infarction (other than the qualifying event) within 5 years
- •d) Ischemic cerebrovascular disease (ischemic stroke or carotid endarterectomy)
- •e) Peripheral vascular disease (symptoms of claudication and/or peripheral revascularization, and/or ankle-brachial index (ABI) < 0.9)
- •f) Heart failure or left ventricular ejection fraction <40% associated with the index ACS event
- •g) Impaired renal function (calculated CrCl < 60 mL/min)
- •h) No revascularization for index ACS event
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Persistent severe hypertension (SBP = 180 mmHg or DBP = 110 mmHg)
- •2) Calculated CrCl < 20 mL/min or on dialysis for end-stage renal disease
- •3) Active bleeding or high risk for bleeding (eg, active peptic ulcer disease, other gastrointestinal pathology with a raised risk of bleeding, liver cirrhosis, malignancies with a raised risk of bleeding)
- •4) Known coagulopathy
- •5) Acute pericarditis
- •6) Recent (< 7 days) ischemic stroke
- •7) NYHA Class IV heart failure at time of randomization
- •8) Any history of intracranial bleeding
- •9) Active and/or significant, known hepatobiliary disease
- •10) Hemoglobin < 9 g/dl
- •11) Platelet count < 100,000 mm³
- •12) Required ongoing treatment with a parenteral or chronic oral anticoagulation (eg, mechanical valve, recent DVT or pulmonary embolism, known left ventricular thrombus)
- •13) Required ongoing treatment with aspirin > 325 mg daily
- •14) Required ongoing treatment with a strong inhibitor of CYP3A4 [azole antifungals (itraconazole and ketoconazole)], macrolide antibiotics (clarithromycin and telithromycin), protease inhibitors [(ritonavir, indinavir, nelfinavir, atazanavir, and saquinavir), and nefazadone)]
- •15) Subjects who participated previously in any other study involving apixaban
- •16) Severe comorbid condition with life expectancy of = 6 months
- •17) Inability to follow the protocol
- •18) Use of an investigational drug or device within 30 days
- •19) Women who are pregnant, breastfeeding, or of childbearing potential and unwilling or unable to use an acceptable method of birth control to avoid pregnancy.
- •20) Prisoners or subjects who are involuntarily incarcerated
- •21) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
研究者
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