Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

October 28, 2015 updated by: Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Shahid ModaressHospital
        • Contact:
        • Principal Investigator:
          • Mohammad Ali Akbarzadeh, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
No antiplatelet drug
Drug: placebo
placebo administration for 3 months after device(PPM,ICD,CRT) implantation
Other Names:
  • placebo 1 tablet daily
Active Comparator: Aspirin
Aspirin 80 mg daily
Drug: Aspirin 80 mg daily
Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
Other Names:
  • Aspirin
Active Comparator: Clopidogrel
Clopidogrel 75mg daily
Drug: Clopidogrel 75 mg daily
Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation
Other Names:
  • Clopidogrel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Morteza Saafi, M.D., Shahid Beheshti University of Medical Sciences
  • Study Director: Mohammad Ali Akbarzadeh, M.D., Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 3, 2015

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVRC100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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