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

Coronary Stenting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966485
• Other study ID #: 84-2230
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: August 25, 2009
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2009
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 67 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Stenting

Intervention

Drug:
• 80 mg ASA dosing

• 500 mg ASA dosing

Locations

Country	Name	City	State
Iran, Islamic Republic of	Namazi hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laboratory ASA resistance		6 months	Yes
Secondary	major adverse cardiac events and positive cardiac scan for ischemia		6 months	Yes