Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
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| ClinicalTrials.gov Identifier: NCT00465270 |
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Recruitment Status :
Completed
First Posted : April 24, 2007
Results First Posted : September 4, 2018
Last Update Posted : February 18, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cryptogenic Stroke | Device: AMPLATZER PFO Occluder Other: Standard of Care - Medical Management | Not Applicable |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 980 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | AMPLATZER PFO Occluder |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) |
| Actual Study Start Date : | August 2003 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Device
AMPLATZER PFO Occluder
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Device: AMPLATZER PFO Occluder
patent foramen ovale closure device |
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Active Comparator: Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
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Other: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole |
- Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization [ Time Frame: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years. ]
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.
Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
- Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who have had a cryptogenic stroke within the last 270 days
- Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
- Subjects willing to participate in follow-up visits
Exclusion Criteria:
- Subjects with intracardiac thrombus or tumor
- Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- Subjects with left ventricular aneurysm or akinesis
- Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
- Subjects with contraindication to aspirin or Clopidogrel therapy
- Pregnant or desire to become pregnant within the next year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465270
Show 69 study locations
| Principal Investigator: | Jeffrey Saver, MD | UCLA Stroke Center | |
| Principal Investigator: | John D Carroll, MD | University of Colorado, Denver | |
| Principal Investigator: | Richard Smalling, MD | University of Texas Houston Health Science Center | |
| Principal Investigator: | David Thaler, MD | Tufts Medical Center |
Publications:
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT00465270 |
| Other Study ID Numbers: |
AGA-006 G990318 |
| First Posted: | April 24, 2007 Key Record Dates |
| Results First Posted: | September 4, 2018 |
| Last Update Posted: | February 18, 2019 |
| Last Verified: | January 2019 |
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Cryptogenic Stroke PFO |
Patent foramen ovale AMPLATZER Occluder |
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Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |