Efficacy of Long Term Plavix Therapy Post Angioplasty

Not Applicable

Completed

• Conditions: Percutaneous Coronary Intervention
• Interventions: Drug: plavix

• Registration Number: NCT02327741
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2012-10
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Study First Submitted: 2014-12-13
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-30
• Results First Submitted: 2020-03-19
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Results First Posted: 2020-04-29
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1010

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plavix long term	plavix	taking plavix more than 12 months
plavix short term	plavix	taking plavix less than 12 months

Primary Outcome Measures

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

Secondary Outcome Measures

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