RESPECT
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment
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Status:
Ongoing. Enrollment began in 2003. CURRENT STATUS AND BASELINE DEMOGRAPHICS per ISC 2010: 576 patients have been enrolled as of June 30, 2009. The graph below depicts progressive enrollment. Index strokes were located in the cerebral cortex (44%), deep white matter [centrum semiovale and internal capsule] (3%), deep grey matter [basal ganglia and thalamus] (10%), brain stem/cerebellum (13%) and in multiple territories (19%). Large infarcts (>3cm) occurred in
22% of the patients. Most subjects (86%) showed PFO-shunting at rest, i.e. without Valsalva. Atrial septal aneurysms (≥10mm) are present in 35%
Purpose:
To investigate whether percutaneous PFO closure is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Interventions:
AMPLATZER PFO Occluder
AMPLATZER® PFO Occluders for heart defect repair utilize the shape memory of Nitinol, a wire made from an alloy of nickel and titanium. Each Occluder is made of a Nitinol wire mesh that is shaped into two flat discs and a middle, or “waist” to pull the discs up to the septum wall. Polyester fabric inserts help close the hole and provide a foundation for growth of tissue over the occluder after placement.
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Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2
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Clopidogrel
Antiplatelet agent
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Dipyridamole
Platelet aggregation inhibitor
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Warfarin
Anticoagulant (Vitamin K antagonist)
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Location(s):
Several U.S. states.
Year Started:
2003
Design:
Multicenter, randomized, active control, blinded adjudicated outcome, clinical trial.
Inclusion Criteria
Patients age 18-60 with patent foramen ovale who have had a cryptogenic stroke within the last 270 days.
Patient Involvement:
Patients are randomly assigned to best medical therapy or PFO closure with the AMPLATZER PFO Occluder. Best medical therapy treatment options include aspirin alone, Coumadin alone, clopidogrel alone, or aspirin combined with dipyridamole.
Primary Outcome:
The primary endpoint is recurrence of non-fatal stroke, post-randomization mortality, or fatal ischemic stroke.
Secondary Outcome:
The secondary endpoints are complete closure of the defect at the six-month follow-up, absence of recurrent symptomatic cryptogenic nonfatal stroke or cardiovascular death, and occurrence of TIA.
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Source of Information:
Presented at the 30th International Stroke Conference [February 2005].
AGA Medical press release June, 2003.
AGA Medical Web site.
Correspondence with trial sponsor [August 2005].
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference [February 2008].
Presented at the 2009 International Stroke Conference [February 2009].
Presented at the 2010 International Stroke Conference [February 2010].
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Web Links and Publications:
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This information last updated on: 2/25/2010
Reviewed on: 02/25/2010.
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Trials
Directories