Efficacy of Long Term Plavix Therapy Post Angioplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: plavix; Drug: plavix

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 Type: Interventional
• Enrollment (Actual): 1010
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: plavix long term; taking plavix more than 12 months	Drug: plavix; taking plavix more than 12 months; Drug: plavix; taking plavix less than 12 months
Active Comparator: plavix short term; taking plavix less than 12 months	Drug: plavix; taking plavix more than 12 months; Drug: plavix; taking plavix less than 12 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Collaborators: Baqiyatallah university of medical sciences
• Investigators: Principal Investigator: javad kojuri, M.D. M.S., shiraz university of medcal sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; clopidogrel; Dual antiplatelet therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: 90-2348