Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Venous Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331511
• Other study ID #: CVRC100
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2015
• Last updated: October 28, 2015
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: hahid Beheshti University of Medical Sciences
• Contact: Mohammad Ali Akbarzadeh, M.D.
• Phone: +98 917 317 1001
• Email: akbarzadehali[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• placebo
placebo administration for 3 months after device(PPM,ICD,CRT) implantation
• Aspirin 80 mg daily
Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
• Clopidogrel 75 mg daily
Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid ModaressHospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)		3 months	No
Secondary	major bleeding		3 months	Yes
Secondary	A composite of death of any cause, myocardial infarction, or cerebrovascular accident.		3 months	Yes