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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | No antiplatelet drug |
|
| Aspirin | Active Comparator | Aspirin 80 mg daily |
|
| Clopidogrel | Active Comparator | Clopidogrel 75mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo administration for 3 months after device(PPM,ICD,CRT) implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| major bleeding | 3 months | |
| A composite of death of any cause, myocardial infarction, or cerebrovascular accident. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Ali Akbarzadeh, M.D. | Contact | +98 917 317 1001 | akbarzadehali@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Morteza Saafi, M.D. | Shahid Beheshti University of Medical Sciences | Study Chair |
| Mohammad Ali Akbarzadeh, M.D. | Shahid Beheshti University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid ModaressHospital | Recruiting | Tehran | Tehran Province | Iran |
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| Aspirin 80 mg daily | Drug | Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation |
|
|
| Clopidogrel 75 mg daily | Drug | Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation |
|
|
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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