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Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

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ClinicalTrials.gov Identifier: NCT00465270
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

April 23, 2007
April 24, 2007
May 25, 2018
September 3, 2018
September 3, 2018
August 2003
May 2012   (Final data collection date for primary outcome measure)
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.

Not Provided
Complete list of historical versions of study NCT00465270 on ClinicalTrials.gov Archive Site
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group [ Time Frame: 6 months ]
Not Provided
Not Provided
Not Provided
 
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
AMPLATZER PFO Occluder
Masking: None (Open Label)
Primary Purpose: Prevention
Cryptogenic Stroke
  • Device: AMPLATZER PFO Occluder
    patent foramen ovale closure device
  • Other: Standard of Care - Medical Management
    Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
  • Experimental: Device
    AMPLATZER PFO Occluder
    Intervention: Device: AMPLATZER PFO Occluder
  • Active Comparator: Standard or Care - Medical Management
    Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
    Intervention: Other: Standard of Care - Medical Management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
980
500
May 2016
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00465270
AGA-006
G990318
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
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
St. Jude Medical
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP