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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • laboratory ASA resistance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

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
Genders Eligible for Study:   Both
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
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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

No publications provided

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
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014