Controlled trial to evaluate the safety and efficacy of the Starflex Septal Closure System
CLOSURE I: Prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the Starflex Septal Closure System vs. best medical therapy in patients with a stroke and/or transient ischemic attack due to presumed paradoxical embolism through a patient foramen ovale To compare the STARFlex device and medication group to the medication-alone group in preventing a recurrent stroke or TIA associated with a PFO. Study conducted in up to 120 centers across the U.S. involving about 800 patients – those with stroke or definite clinical TIA within 6 months, without other definable cause.
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial (POINT)
The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke. Patients who have had a TIA have a higher risk of developing a stroke. Recognizing and treating TIAs can reduce the risk of a stroke. Both aspirin and clopidogrel, medications that prevent blood clots from forming, when used alone, have been shown to be effective in preventing strokes. Several studies that tested the combination of clopidogrel and aspirin have suggested that taking these two medications together may protect patients even more from major stroke and heart attack after a TIA or minor stroke, in comparison to taking aspirin alone, but these studies were small and the risk of bleeding was increased. The POINT trial has been designed to find out whether the combination of aspirin and clopidogrel reduces the risk of stroke, heart attacks and other complications compared to aspirin alone.
WARCEF - Warfarn vs. Aspirin in Reduced Cardiac Ejection Fraction
WARCEF - Warfarn vs. Aspirin in Reduced Cardiac Ejection Fraction. Includes Change in Eligibility Criteria (Eligibility Ejection Fraction Has Been Increased From less than 30 to less than 35%) To compare the efficacy and safety of Warfarin (INR 2.0-3.0) with aspirin (325 mg per day) for preventing all-cause mortality and disability in patients with cardiac EF less than 35%.