Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-06-30

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.

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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.

Conditions

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Complication of Cardiac Defibrillator Disorder of Cardiac Pacemaker System Venous Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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placebo

No antiplatelet drug

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo administration for 3 months after device(PPM,ICD,CRT) implantation

Aspirin

Aspirin 80 mg daily

Group Type ACTIVE_COMPARATOR

Aspirin 80 mg daily

Intervention Type DRUG

Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation

Clopidogrel

Clopidogrel 75mg daily

Group Type ACTIVE_COMPARATOR

Clopidogrel 75 mg daily

Intervention Type DRUG

Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Interventions

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placebo

placebo administration for 3 months after device(PPM,ICD,CRT) implantation

Intervention Type DRUG

Aspirin 80 mg daily

Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation

Intervention Type DRUG

Clopidogrel 75 mg daily

Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Intervention Type DRUG

Other Intervention Names

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placebo 1 tablet daily Aspirin Clopidogrel

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No