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Genotypic and Phenotypic Correlates of Resistance to Aspirin (ARSENAL)

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ClinicalTrials.gov Identifier: NCT01361620
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
George Washington University

Brief Summary:
The study seeks to identify genomic markers associated with aspirin resistance.

Condition or disease Intervention/treatment Phase
Platelet Dysfunction Due to Aspirin Drug: aspirin Not Applicable

Detailed Description:
Not desired

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Genotypic and Phenotypic Correlates of Resistance to Anti-platelet Actions of Aspirin in an At-risk Patient Population and in the General Population
Study Start Date : December 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Aspirin
All subjects took 7-10 days of 81 mg aspirin
Drug: aspirin
aspirin 81mg, 7-10 days




Primary Outcome Measures :
  1. Whole Blood Coagulation [ Time Frame: Single measurement at 7-10 days after beginning aspirin ]
    Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.

Exclusion Criteria:

  • Patient requiring more than 81 mg aspirin daily
  • Known GI bleeding attributed to ASA
  • Active peptic ulcer disease or history within the last year
  • Known aspirin allergy
  • Current use of:

    • warfarin,
    • heparin,
    • NSAIDs (except aspirin),
    • clopidogrel,
    • dipyridamole,
    • fish-oil/omega 3 supplements,
  • Women of childbearing potential who are pregnant, planning to become pregnant or nursing.

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 ClinicalTrials.gov identifier (NCT number): NCT01361620


Locations
United States, District of Columbia
GWU Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Jonathan Reiner, MD GWU Medical Faculty

Publications of Results:
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01361620     History of Changes
Other Study ID Numbers: AR2011
First Posted: May 27, 2011    Key Record Dates
Results First Posted: December 16, 2013
Last Update Posted: December 16, 2013
Last Verified: January 2011

Keywords provided by George Washington University:
genomic markers
aspirin resistance

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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics