Phase III Acute Coronary Syndrome APPRAISE-2
- Conditions
- -I20-I21-I22I20I21I22
- Registration Number
- PER-035-09
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method