Efficacy of Long Term Plavix Therapy Post Angioplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1010 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-31

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.

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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.

Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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plavix long term

taking plavix more than 12 months

Group Type EXPERIMENTAL

plavix

Intervention Type DRUG

taking plavix more than 12 months

plavix short term

taking plavix less than 12 months

Group Type ACTIVE_COMPARATOR

plavix

Intervention Type DRUG

taking plavix less than 12 months

Interventions

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plavix

taking plavix more than 12 months

Intervention Type DRUG

plavix

taking plavix less than 12 months

Intervention Type DRUG

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No