Efficacy of Long Term Plavix Therapy Post Angioplasty

Shiraz University of Medical Sciences1,010 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,010

Conditions

Percutaneous Coronary Intervention

Interventions

plavixDRUG

taking plavix more than 12 months

plavixDRUG

taking plavix less than 12 months

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Patients With Major Bleeding Need Transfusion

number of patients with major bleeding need transfusion

Time frame: 12 months

Number of Patients With Myocardial Infarction Need Hospital Admission

The number of patients with myocardial infarction need hospital admission

Time frame: 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

Time frame: 12 months

Number of Patients With Death Due to Cardiac Causes

the number patients with death due to cardiac causes

Time frame: 12 months

Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty

need for redo bypass surgery and redo angioplasty

Time frame: 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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

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