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

NCT ID: NCT00966485

Last Updated: 2009-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Stenting

Keywords

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ASA resistance coronary stenting platelet function laboratory ASA resistance MACE Positive SPECT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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80 mg ASA dose

6 months post stent on 80 mg ASA

Group Type ACTIVE_COMPARATOR

80 mg ASA dosing

Intervention Type DRUG

500 mg ASA dose

6 months posr stent on ASA alone

Group Type ACTIVE_COMPARATOR

500 mg ASA dosing

Intervention Type DRUG

Interventions

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80 mg ASA dosing

Intervention Type DRUG

500 mg ASA dosing

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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shiraz University of medical sciences

Principal Investigators

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javad kojuri, M.D.

Role: STUDY_CHAIR

Shiraz University of Medical Sciences

Locations

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Namazi hospital

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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84-2230

Identifier Type: -

Identifier Source: org_study_id