To determine the efficacy and safety of conventional- and low-intensity warfarin therapy in non-valvular atrial fibrillation (NVAF).
- Warfarin (Coumadin®)Drug
Other Names: Coumadin Intervention Desc: Anticoagulant (Vitamin K antagonist)
Prospective, randomized, open-label trial of 115 patients at 19 centers.
The patients were randomly allocated into a conventional-intensity group (international normalized ratio [INR] 2.2 to 3.5) and a low-intensity group (INR 1.5 to 2.1). A brain CT scan, MRI examination, or both were performed once a year, regardless of the patient’s outcome. Patient follow-up continued for at least 2 years or until end point events occurred.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Brain infarction, embolism to other parts of the body, TIA, amaurosis fugax, or asymptomatic brain infarction confirmed with CT scanning or MRI.|
|Secondary||Brain hemorrhage, retinal hemorrhage, or other severe hemorrhagic complications that were fatal; hospital admission for emergency treatment; or blood transfusion.|