Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02331511

Enrollment

100

Registered

2015-01-06

Start date

2015-10-31

Completion date

2016-06-30

Last updated

2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion

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.

Interventions

DRUGplacebo

placebo administration for 3 months after device(PPM,ICD,CRT) implantation

DRUGAspirin 80 mg daily

Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation

DRUGClopidogrel 75 mg daily

Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

Iran

Contacts

Primary ContactMohammad Ali Akbarzadeh, M.D.

akbarzadehali@yahoo.com+98 917 317 1001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026