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Trial record 16 of 469 for:    aspirin AND prevention

Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02331511
Recruitment Status : Unknown
Verified October 2015 by Mohammad Ali Akbarzadeh, Shahid Beheshti Medical University.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Complication of Cardiac Defibrillator Disorder of Cardiac Pacemaker System Venous Occlusion Drug: placebo Drug: Aspirin 80 mg daily Drug: Clopidogrel 75 mg daily

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
Study Start Date : October 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo
No antiplatelet drug
Drug: placebo
placebo administration for 3 months after device(PPM,ICD,CRT) implantation
Other Name: 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 Name: Aspirin
Active Comparator: Clopidogrel
Clopidogrel 75mg daily
Drug: Clopidogrel 75 mg daily
Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation
Other Name: Clopidogrel


Outcome Measures

Primary Outcome Measures :
  1. Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. major bleeding [ Time Frame: 3 months ]
  2. A composite of death of any cause, myocardial infarction, or cerebrovascular accident. [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331511


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

Locations
Iran, Islamic Republic of
Shahid ModaressHospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Ali Akbarzadeh, M.D    (+98)9173171001    akbarzadehali@yahoo.com   
Principal Investigator: Mohammad Ali Akbarzadeh, M.D         
Sponsors and Collaborators
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
More Information

Responsible Party: Mohammad Ali Akbarzadeh, Assistant proffesor of shahid beheshti university of medical sciences, Shahid Beheshti Medical University
ClinicalTrials.gov Identifier: NCT02331511     History of Changes
Other Study ID Numbers: CVRC100
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors