Status unknownNCT02331511Updated Oct 29, 2015

Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

An interventional study of placebo and Aspirin 80 mg daily in Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System and Venous Occlusion, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-29.

Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Complication of Cardiac Defibrillator
Disorder of Cardiac Pacemaker System
Venous Occlusion

In context

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Placebo comparator
placebo
No antiplatelet drug
Drug: placebo
Active comparator
Aspirin
Aspirin 80 mg daily
Drug: Aspirin 80 mg daily
Active comparator
Clopidogrel
Clopidogrel 75mg daily
Drug: Clopidogrel 75 mg daily

Interventions

Drugplacebo
placebo administration for 3 months after device(PPM,ICD,CRT) implantation
Also known as: placebo 1 tablet daily
DrugAspirin 80 mg daily
Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
Also known as: Aspirin
DrugClopidogrel 75 mg daily
Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation
Also known as: Clopidogrel

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Shahid ModaressHospital
Tehran, Iran, Islamic Republic of
- Mohammad Ali Akbarzadeh, M.D · Contact · akbarzadehali@yahoo.com · (+98)9173171001
- Mohammad Ali Akbarzadeh, M.D · Principal investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02331511
Lead sponsor: Shahid Beheshti University of Medical Sciences
Responsible party: Mohammad Ali Akbarzadeh (Assistant proffesor of shahid beheshti university of medical sciences, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted: Jan 6, 2015
Start date: Oct 2015
Primary completion: May 2016 (estimated)
Completion: Jun 2016 (estimated)
Last update: Oct 29, 2015

Study contacts

Mohammad Ali Akbarzadeh, M.D.

Contact

akbarzadehali@yahoo.com

+98 917 317 1001

Morteza Saafi, M.D.

study chair · Shahid Beheshti University of Medical Sciences

Mohammad Ali Akbarzadeh, M.D.

study director · Shahid Beheshti University of Medical Sciences

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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