None listed
Conditions
Interventions
Group 1 Type of group
Apixaban tablets, Oral, 5 mg, twice daily, until study end
Group name:Group 2 Type of group
Placebo tablets, Oral, 0 mg, twice daily, until study end
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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)
Exclusion criteria
Exclusion criteria: • Persistent severe hypertension (PAS> 180 mmHg or PAD> 110 mmHg) • ICRC calculated 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). Measure:Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants Timepoints:Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years ; Outcome name:TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days. Measure:Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarct | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). Measure:Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants Timepoints:Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years ; Outcome name:Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomiz | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Korea South, Malasya, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactLuis Miguel Melendez
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed