Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Not Applicable

• Conditions: Venous Occlusion; Complication of Cardiac Defibrillator; Disorder of Cardiac Pacemaker System
• Interventions: Drug: Aspirin 80 mg daily; Drug: Clopidogrel 75 mg daily; Drug: placebo

• Registration Number: NCT02331511
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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 Timeline

• Study First Submitted: 2015-01-03
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Status Verified: 2015-10
• Study Start: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin 80 mg daily	Aspirin 80 mg daily
Clopidogrel	Clopidogrel 75 mg daily	Clopidogrel 75mg daily
placebo	placebo	No antiplatelet drug

Primary Outcome Measures

Name	Time	Method
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)	3 months

Secondary Outcome Measures

Name	Time	Method
major bleeding	3 months
A composite of death of any cause, myocardial infarction, or cerebrovascular accident.	3 months

Trial Locations

Locations (1)

Shahid ModaressHospital; 🇮🇷 Tehran, Iran, Islamic Republic of