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Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complication of Cardiac Defibrillator; Disorder of Cardiac Pacemaker System; Venous Occlusion

Intervention: placebo (Drug); Aspirin 80 mg daily (Drug); Clopidogrel 75 mg daily (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Shahid Beheshti Medical University

Official(s) and/or principal investigator(s):
Morteza Saafi, M.D., Study Chair, Affiliation: Shahid Beheshti Medical University
Mohammad Ali Akbarzadeh, M.D., Study Director, Affiliation: Shahid Beheshti Medical University

Overall contact:
Mohammad Ali Akbarzadeh, M.D., Phone: +98 917 317 1001, Email: akbarzadehali@yahoo.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)

Secondary outcome:

major bleeding

A composite of death of any cause, myocardial infarction, or cerebrovascular accident.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Mohammad Ali Akbarzadeh, M.D., Phone: +98 917 317 1001, Email: akbarzadehali@yahoo.com

Additional Information

Starting date: July 2015
Last updated: June 12, 2015

Page last updated: August 23, 2015

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