Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Shahid Beheshti University of Medical Sciences

Status: Unknown

Conditions: Disorder of Cardiac Pacemaker System; Complication of Cardiac Defibrillator; Venous Occlusion

Treatments: Drug: Aspirin 80 mg daily; Drug: Clopidogrel 75 mg daily; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02331511

CVRC100

Details and patient eligibility

About

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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

No antiplatelet drug

Treatment:

Drug: placebo

Aspirin

Active Comparator group

Description:

Aspirin 80 mg daily

Treatment:

Drug: Aspirin 80 mg daily

Clopidogrel

Active Comparator group

Description:

Clopidogrel 75mg daily

Treatment:

Drug: Clopidogrel 75 mg daily