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)
2 other identifiers
interventional
980
2 countries
69
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2003
Longer than P75 for not_applicable
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 23, 2007
CompletedFirst Posted
Study publicly available on registry
April 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
September 4, 2018
CompletedFebruary 18, 2019
January 1, 2019
8.8 years
April 23, 2007
May 25, 2018
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
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.
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.
Secondary Outcomes (1)
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
6 months
Study Arms (2)
Device
EXPERIMENTALAMPLATZER PFO Occluder
Standard or Care - Medical Management
ACTIVE COMPARATORMedical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Interventions
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
University of Alabama
Birmingham, Alabama, 35249, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
LAC + USC Medical Center
Los Angeles, California, 90033, United States
UCLA
Los Angeles, California, 90095, United States
Summit Medical Center
Oakland, California, 94609, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Kaiser Permanente
San Francisco, California, 94115, United States
University of Colorado
Denver, Colorado, 80262, United States
South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
St. Vincent's Medical Center
Jacksonville, Florida, 32204, United States
Northwestern University
Chicago, Illinois, 60611-3078, United States
University of Chicago
Chicago, Illinois, 60637-1470, United States
Neurologic Associates Inc
Palos Heights, Illinois, 60463, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Southern Illinois University Neurology
Springfield, Illinois, 62702, United States
Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
Ruan Neurology
Des Moines, Iowa, 50314, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Midatlantic Cardiovascular Associates
Towson, Maryland, 21014, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-0316, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Methodist Hospital/Park Nicollet Medical Center
Saint Louis Park, Minnesota, 55426, United States
Washington University
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2045, United States
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, 08034, United States
University of Medicine and Dentistry of New Jersy
Newark, New Jersey, 07103, United States
Albany Medical Center
Albany, New York, 12208, United States
DENT Neurologic Institute
Amherst, New York, 14226, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27410, United States
Neurology and Neuroscience Associates
Akron, Ohio, 44320, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
Providence St. Vincent's Medical Center
Portland, Oregon, 97225, United States
Oregon Stroke Center, OHSU
Portland, Oregon, 97329, United States
LeHigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Penn State Milton South Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17543, United States
St. Mary's Medical Center
Langhorne, Pennsylvania, 19067, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
North Central Heart Institute
Sioux Falls, South Dakota, 57108, United States
St. Thomas Neurology
Nashville, Tennessee, 37205, United States
Vanderbilt University
Nashville, Tennessee, 37232-8802, United States
UT Southwestern Medical School
Dallas, Texas, 75390-8897, United States
University of Texas Houston Health Science Center
Houston, Texas, 77030, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454, United States
UW Medicine Stroke Center
Seattle, Washington, 98104, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W5, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital
Vancouver, British Columbia, V5Z 1Y6, Canada
Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
London, Ontario, N6G 2V2, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Related Publications (2)
Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.
PMID: 28902590BACKGROUNDCarroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.
PMID: 23514286BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Laura O'Brien
- Organization
- Abbott
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 23, 2007
First Posted
April 24, 2007
Study Start
August 1, 2003
Primary Completion
May 1, 2012
Study Completion
May 1, 2016
Last Updated
February 18, 2019
Results First Posted
September 4, 2018
Record last verified: 2019-01