Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Conditions
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Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion

Intervention / Treatment
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* Drug: placebo
* Drug: Aspirin 80 mg daily
* Drug: Clopidogrel 75 mg daily


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>No antiplatelet drug | Drug: placebo<br>* placebo administration for 3 months after device(PPM,ICD,CRT) implantation<br>* Other names: placebo 1 tablet daily;|
| Active Comparator: Aspirin<br>Aspirin 80 mg daily | Drug: Aspirin 80 mg daily<br>* Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation<br>* Other names: Aspirin;|
| Active Comparator: Clopidogrel<br>Clopidogrel 75mg daily | Drug: Clopidogrel 75 mg daily<br>* Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation<br>* Other names: Clopidogrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major bleeding |  | 3 months | 
| A composite of death of any cause, myocardial infarction, or cerebrovascular accident. |  | 3 months |