Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome

BRISTOL MYERS SQUIBB COMPANY,0 个研究点目标入组 0 人开始时间: 2009年5月20日最近更新: 2023年9月4日

适应症

试验速览

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•Age> 18 years.
•Acute coronary syndrome (MI or unstable angina with ST elevation or no ST elevation) within 7 days
•Having completed parenteral treatment with anticoagulanles for the SCA index event.
•Clinically stable, with standard medical care for ACS, including single antiplatelet therapy (aspirin or a P2Y12 antagonist) or double (aspirin plus a P2Y12 antagonist) according to the criteria of the attending physician.
•Two or more of the following risk factors: Age> 65 years, Diabetes mellitus, History of myocardial infarction (other than the event that meets the criteria) within the last 5 years, Ischemic cerebrovascular disease (ischemic attack or cartide endarterectomy) , Peripheral vascular disease (symptoms of claudication and / or peripheral revascularization, and / or ankle-brachial index (ABl) <0.9), Heart failure or left ventricular ejection fraction <40% associated with the ACS index event, Impaired renal function (ClCr <60 ml / min)

•Persistent severe hypertension (PAS> 180 mmHg or PAD> 110 mmHg)
•ICRC calculated <20 ml / min or on dialysis for end-stage renal disease
•Active hemorrhage or high risk of major bleeding (eg active peptic ulcer, another gastrointestinal pathology with high risk of bleeding, liver cirrhosis, malignancy with high risk of bleeding)
•Known coagulopathy
•Acute pericarditis
•Recent ischemic attack (<7 days)
•History of intracranial hemorrhage
•Class IV heart failure according to the NYHA at the time of randomization
•Active and / or significant known hepatobiliary disease
•Hemoglobin <9 g / dl
•Platelet count <100,000 mm3
•Ongoing treatment with a parenteral anticoagulant or in chronic treatment with an oral anticoagulant (eg mechanical valve, DVT or recent pulmonary embolism, known left ventricular thrombus)
•Ongoing treatment with daily doses of> 325 mg of aspirin
•Ongoing treatment with a potent CYP3A4 inhibitor (azolic antifungals (traconzaol and ketoconazole), macrolide antibiotics (clarithromycin and telithromycin), protease inhibitors (ritonavir, indinavir, nelfinavir, atazanavir and saquinavir) and nefazadone)

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