Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
Overview
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
placebo
No antiplatelet drug
Intervention: placebo (Drug)
Aspirin
Aspirin 80 mg daily
Intervention: Aspirin 80 mg daily (Drug)
Clopidogrel
Clopidogrel 75mg daily
Intervention: Clopidogrel 75 mg daily (Drug)
Outcomes
Primary Outcomes
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
Time Frame: 3 months
Secondary Outcomes
- major bleeding(3 months)
- A composite of death of any cause, myocardial infarction, or cerebrovascular accident.(3 months)
Investigators
Mohammad Ali Akbarzadeh
Assistant proffesor of shahid beheshti university of medical sciences
Shahid Beheshti University of Medical Sciences