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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
AFASAK II
Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study



Principal Investigator
A.L. Gullov

PI Address
Copenhagen General Practitioners Laboratory
Denmark

Contact Address
A.L. Gullov, M.D., Glostrup Hospital, Department of Rheumatology U, Glostrup Ringrej, DK-2600 Glostrup, Denmark

Contact Email
Gullov@dadlnet.dk



Trial Phase:Phase III
Study Size Actual:677
Centers Actual:1
Min Age:18
Status:
Trial complete. Results published in June of 1998.

Purpose:
To investigate the effect of minidose warfarin alone and in combination with aspirin in patients with chronic nonvalvular atrial fibrillation.

Interventions:
Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2
Warfarin
Anticoagulant (Vitamin K antagonist)

Year Published: 1998


Design:
Randomized, controlled trial of 677 patients at a single center.

Inclusion Criteria
Nonvalvular chronic atrial fibrillation, aged 18 years or older.

Exclusion Criteria
Aged less than 60 with lone atrial fibrillation; systolic or diastolic blood pressure above 180/100 mm Hg, stroke, transient ischemic attack within 6 months, risk factors for bleeding, contraindications for warfarin or aspirin, already receiving adjusted-dose warfarin.

Patient Involvement:
Patients were assigned to receive warfarin sodium (1.25 mg/d), warfarin sodium (1.25 mg/d) plus aspirin (300 mg/d), aspirin (300 mg/d), or adjusted-dose warfarin with an INR of 2.0 to 3.0.

Primary Outcome:
Stroke or a systemic thromboembolic event.

Secondary Outcome:
Transient ischemic attack, acute myocardial infarction, and death.

Results:
The cumulative rate of primary endpoint after 1 year was 5.8% in patients receiving minidose warfarin, 7.2% in patients receiving warfarin plus aspirin, 3.6% in patients receiving aspirin alone and 2.8% in patients receiving adjusted-rate warfarin. No difference was found between the groups after 3 years.

Source of Information:
Arch Intern Med 1998 Jul 27;158(14):1513-21

Web Links and Publications:
Bleeding during warfarin and aspirin therapy in patients with atrial fibrillation: the AFASAK 2 study. Atrial Fibrillation Aspirin and Anticoagulation.
Arch Intern Med. 1999 Jun 28;159(12):1322-8.

Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation.
Arch Intern Med 1998 Jul 27;158(14):1513-21

This information last updated on: 10/3/2000

UID: 63

   

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