The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Warfarin (Coumadin®)Drug
Intervention Desc: Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day ARM 1: Kind: Experimental Label: Warfarin Description: Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
- Aspirin Drug
Intervention Desc: Aspirin 325 mg once a day; placebo warfarin once a day ARM 1: Kind: Experimental Label: Aspirin Description: Aspirin 325 mg plus placebo warfarin
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
Following enrollment in the study, patients received TE to assess whether or not they had a PFO, and their baseline strokes were subtyped by a neurologist. They were then randomized to receive either 325 mg aspirin and a warfarin-resembling placebo (n = 318) or 2 mg warfarin and an aspirin-resembling placebo (n = 312). They were briefly evaluated wither over the phone or in person every month, and received detailed examinations in person every quarter for two years.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Recurrent ischemic stroke or death.|
|Primary||Recurrent ischemic stroke and death||2 years||No|