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Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

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ClinicalTrials.gov Identifier: NCT02331511
Recruitment Status : Unknown
Verified October 2015 by Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 3, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date October 29, 2015
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
Venus obstruction more than 50%(measure by venography) [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT02331511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • major bleeding [ Time Frame: 3 months ]
  • A composite of death of any cause, myocardial infarction, or cerebrovascular accident. [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
Official Title  ICMJE Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
Brief Summary The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
Detailed Description There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Complication of Cardiac Defibrillator
  • Disorder of Cardiac Pacemaker System
  • Venous Occlusion
Intervention  ICMJE
  • Drug: placebo
    placebo administration for 3 months after device(PPM,ICD,CRT) implantation
    Other Name: placebo 1 tablet daily
  • Drug: Aspirin 80 mg daily
    Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
    Other Name: Aspirin
  • Drug: Clopidogrel 75 mg daily
    Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation
    Other Name: Clopidogrel
Study Arms  ICMJE
  • Placebo Comparator: placebo
    No antiplatelet drug
    Intervention: Drug: placebo
  • Active Comparator: Aspirin
    Aspirin 80 mg daily
    Intervention: Drug: Aspirin 80 mg daily
  • Active Comparator: Clopidogrel
    Clopidogrel 75mg daily
    Intervention: Drug: Clopidogrel 75 mg daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 5, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device

Exclusion Criteria:

  • history of malignancy
  • history of coagulopathy or platelet disorder
  • history of venous thromboembolism
  • history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
  • history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
  • patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331511
Other Study ID Numbers  ICMJE CVRC100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Morteza Saafi, M.D. Shahid Beheshti University of Medical Sciences
Study Director: Mohammad Ali Akbarzadeh, M.D. Shahid Beheshti University of Medical Sciences
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date October 2015

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