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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Cryptogenic Stroke
Interventions: Device: AMPLATZER PFO Occluder
Other: Standard of Care - Medical Management

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Device AMPLATZER PFO Occluder: patent foramen ovale closure device
Medical Management Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.

Participant Flow:   Overall Study
    Device   Medical Management
STARTED   499   481 
COMPLETED   395   321 
NOT COMPLETED   104   160 
Death                7                11 
Withdrawal by Subject                34                78 
Lost to Follow-up                60                67 
Investigator request                3                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Device AMPLATZER PFO Occluder: patent foramen ovale closure device
Medical Management Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
Total Total of all reporting groups

Baseline Measures
   Device   Medical Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 499   481   980 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.7  (9.7)   46.2  (10.0)   45.9  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      231  46.3%      213  44.3%      444  45.3% 
Male      268  53.7%      268  55.7%      536  54.7% 


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group   [ Time Frame: 6 months ]

3.  Post-Hoc:   Rate of Recurrent Nonfatal Stroke, Post-randomization Death, and Fatal Ischemic Stroke Through Long Term Follow-up   [ Time Frame: Long Term Follow-up, median of 5.9 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Laura O'Brien
Organization: Abbott
e-mail: laura.obrien@abbott.com


Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00465270     History of Changes
Other Study ID Numbers: AGA-006
G990318
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: May 25, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018