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

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00966485

Collaborator

(none)

106

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Stenting	Drug: 80 mg ASA dosing Drug: 500 mg ASA dosing	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 80 mg ASA dose 6 months post stent on 80 mg ASA	Drug: 80 mg ASA dosing
Active Comparator: 500 mg ASA dose 6 months posr stent on ASA alone	Drug: 500 mg ASA dosing

Arm

Intervention/Treatment

Active Comparator: 80 mg ASA dose

6 months post stent on 80 mg ASA

Drug: 80 mg ASA dosing

Active Comparator: 500 mg ASA dose

6 months posr stent on ASA alone

Drug: 500 mg ASA dosing

Outcome Measures

Primary Outcome Measures

laboratory ASA resistance [6 months]

Secondary Outcome Measures

major adverse cardiac events and positive cardiac scan for ischemia [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Namazi hospital	Shiraz	Fars	Iran, Islamic Republic of	55318

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

Study Chair: javad kojuri, M.D., Shiraz University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00966485

Other Study ID Numbers:

84-2230

First Posted:

Aug 27, 2009

Last Update Posted:

Aug 27, 2009

Last Verified:

Aug 1, 2009

Keywords provided by , ,

ASA resistance

coronary stenting

platelet function

laboratory ASA resistance

MACE

Positive SPECT

Study Results

No Results Posted as of Aug 27, 2009