Dose-related Effect of Aspirin on Laboratory-defined Acetylsalicylic Acid Resistance and Clinical Outcome After Coronary Stenting

Not Applicable

Completed

• Conditions: Coronary Stenting
• Interventions: Drug: 500 mg ASA dosing; Drug: 80 mg ASA dosing

• Registration Number: NCT00966485
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

The investigators prospectively studied the effect of aspirin on platelet function in 106 stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6 months).T

Detailed Description

Background:

Acetylsalicylic acid (aspirin) is widely used in the secondary prevention of coronary artery disease. There is controversy regarding the prevalence of aspirin resistance in patients with coronary artery disease and the effect of dose on resistance. Our primary aims were to determine the degree of platelet responsiveness to aspirin, and to study the influence of dose on platelet inhibition and clinical outcomes after coronary stenting.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-25
• Last Update Submitted: 2009-08-25
• Study First Posted: 2009-08-27
• Last Update Posted: 2009-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 6 months post stent without complication

Exclusion Criteria

• subacute stent thrombosis
• unable to discontinue plavix
• dont accept to participate
• contraindication for ASA use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500 mg ASA dose	500 mg ASA dosing	6 months posr stent on ASA alone
80 mg ASA dose	80 mg ASA dosing	6 months post stent on 80 mg ASA

Primary Outcome Measures

Name	Time	Method
laboratory ASA resistance	6 months

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac events and positive cardiac scan for ischemia	6 months

Trial Locations

Locations (1)

Namazi hospital; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of