Efficacy of Long Term Plavix Therapy Post Angioplasty

Study Overview
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Brief Summary
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1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.

Detailed Description
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1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.

Official Title
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Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: plavix
* Drug: plavix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: post stent ( lesion more than 70% and vessel more than 2.25 mm ) Exclusion Criteria: allergy to acetylsalicylic acid or clopidogrel, planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period history of bleeding diathesis major surgery within 15 days active bleeding previous stroke in the past 6 months concomitant or foreseeable need for oral anticoagulation therapy pregnancy, life expectancy <24 months, participation in another trial inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: plavix long term<br>taking plavix more than 12 months | Drug: plavix<br>* taking plavix more than 12 months<br>|
| Active Comparator: plavix short term<br>taking plavix less than 12 months | Drug: plavix<br>* taking plavix less than 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Major Bleeding Need Transfusion | number of patients with major bleeding need transfusion | 12 months | 
| Number of Patients With Myocardial Infarction Need Hospital Admission | The number of patients with myocardial infarction need hospital admission | 12 month | 
| Number of Patients With Central Vascular Accidents Proved by CT Scan | the number of patients with major vascular brain accidents ( CVA) proved by CT scan | 12 months | 
| Number of Patients With Death Due to Cardiac Causes | the number patients with death due to cardiac causes | 12 months | 
| Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty | need for redo bypass surgery and redo angioplasty | 12 months | 
| Number of Patients With Minor Bleeding | the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues | the number of patients who are able to take plavix concerning compliance and economic issues | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual antiplatelet therapy, clopidogrel, percutaneous coronary intervention