Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Overview

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.

Full Title of Study: “Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

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.

Interventions

  • Drug: placebo
    • placebo administration for 3 months after device(PPM,ICD,CRT) implantation
  • Drug: Aspirin 80 mg daily
    • Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
  • Drug: Clopidogrel 75 mg daily
    • Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
    • No antiplatelet drug
  • Active Comparator: Aspirin
    • Aspirin 80 mg daily
  • Active Comparator: Clopidogrel
    • Clopidogrel 75mg daily

Clinical Trial Outcome Measures

Primary Measures

  • Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
    • Time Frame: 3 months

Secondary Measures

  • major bleeding
    • Time Frame: 3 months
  • A composite of death of any cause, myocardial infarction, or cerebrovascular accident.
    • Time Frame: 3 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammad Ali Akbarzadeh, Assistant proffesor of shahid beheshti university of medical sciences – Shahid Beheshti University of Medical Sciences
  • Overall Official(s)
    • Morteza Saafi, M.D., Study Chair, Shahid Beheshti University of Medical Sciences
    • Mohammad Ali Akbarzadeh, M.D., Study Director, Shahid Beheshti University of Medical Sciences
  • Overall Contact(s)
    • Mohammad Ali Akbarzadeh, M.D., +98 917 317 1001, akbarzadehali@yahoo.com

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