APPRAISE-1 (10mg od) study - description and results

4 arms: 20mg daily, 10mg twice daily, 10mg daily and 2.5mg twice daily. 10mg twice daily and 20mg once daily were discontinued due to an excess of major and minor bleeding

Patients

patients with a recent ST-elevation or non–ST-elevation acute coronary syndrome(<7 days)

Inclusion criteria

between 18 and 90 years of age; recent (within 7 days) ST-elevation or non–ST-elevation ACS; clinically stable; receiving evidence based care; at least 1 additional risk factor for recurrent ischemic events

Exclusion criteria

aspirin allergy; planned catheterization, percutaneous coronary intervention, coronary bypass surgery, or other invasive procedure; persistent severe hypertension; severe renal insufficiency; active bleeding or high risk for bleeding; coagulopathy; acute pericarditis or pericardial effusion; stroke within 3 months; NYHA class IV heart failure; thrombocytopenia; anemia; indication for ongoing anticoagulation; long-term nonsteroidal antiinflammatory drug or high-dose aspirin use; ongoing treatment with strong CYP3A4 inhibitors

Method and design

Randomized effectives

318 / 611 (studied vs. control)

Design

Parallel groups

Blinding

double blind

Follow-up duration

6 months

Number of centre

151

Geographic area

Europe, Middle East, North America

Primary endpoint

major or clinically relevant nonmajor bleeding

Remarks

dose-finding study

Reference(s)

Trials register #

NCT00313300

. Apixaban, an Oral, Direct, Selective Factor Xa Inhibitor, in Combination With Antiplatelet Therapy After Acute Coronary Syndrome. Results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) Trial.. Circulation 2009;:

Pubmed | Hubmed | Fulltext

External links about this trial

APPRAISE-1 (10mg od) study, 2009

Treatments

Patients

Method and design

Results

Reference(s)

External links about this trial