Genotypic and Phenotypic Correlates of Resistance to Aspirin (ARSENAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01361620
First received: May 25, 2011
Last updated: October 29, 2013
Last verified: January 2011
  Purpose

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


Condition Intervention
Platelet Dysfunction Due to Aspirin
Drug: aspirin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Whole Blood Coagulation [ Time Frame: Single measurement at 7-10 days after beginning aspirin ] [ Designated as safety issue: No ]
    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.


Enrollment: 190
Study Start Date: December 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aspirin
All subjects took 7-10 days of 81 mg aspirin
Drug: aspirin
aspirin 81mg, 7-10 days

Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

Publications:
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01361620     History of Changes
Other Study ID Numbers: AR2011
Study First Received: May 25, 2011
Results First Received: August 19, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
genomic markers
aspirin resistance

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
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 31, 2014