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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00966485
First received: August 24, 2009
Last updated: August 25, 2009
Last verified: August 2009
  Purpose
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 Intervention
Coronary Stenting Drug: 80 mg ASA dosing Drug: 500 mg ASA dosing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Shiraz University of Medical Sciences:

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

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

Enrollment: 106
Study Start Date: October 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966485

Locations
Iran, Islamic Republic of
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
  More Information

Responsible Party: Kojuri J, shiraz University of medical sciences
ClinicalTrials.gov Identifier: NCT00966485     History of Changes
Other Study ID Numbers: 84-2230
Study First Received: August 24, 2009
Last Updated: August 25, 2009

Keywords provided by Shiraz University of Medical Sciences:
ASA resistance
coronary stenting
platelet function
laboratory ASA resistance
MACE
Positive SPECT

ClinicalTrials.gov processed this record on September 25, 2017