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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966485
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : August 27, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Coronary Stenting Drug: 80 mg ASA dosing Drug: 500 mg ASA dosing Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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

Primary Outcome Measures :
  1. laboratory ASA resistance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. major adverse cardiac events and positive cardiac scan for ischemia [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00966485

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Iran, Islamic Republic of
Namazi hospital
Shiraz, Fars, Iran, Islamic Republic of, 55318
Sponsors and Collaborators
Shiraz University of Medical Sciences
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Study Chair: javad kojuri, M.D. Shiraz University of Medical Sciences
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Responsible Party: Kojuri J, shiraz University of medical sciences Identifier: NCT00966485    
Other Study ID Numbers: 84-2230
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: August 27, 2009
Last Verified: August 2009
Keywords provided by Shiraz University of Medical Sciences:
ASA resistance
coronary stenting
platelet function
laboratory ASA resistance
Positive SPECT