Genotypic and Phenotypic Correlates of Resistance to Aspirin
ARSENAL
1 other identifier
interventional
190
1 country
1
Brief Summary
The study seeks to identify genomic markers associated with aspirin resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedResults Posted
Study results publicly available
December 16, 2013
CompletedDecember 16, 2013
January 1, 2011
3.3 years
May 25, 2011
August 19, 2013
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whole Blood Coagulation
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.
Single measurement at 7-10 days after beginning aspirin
Study Arms (1)
Aspirin
OTHERAll subjects took 7-10 days of 81 mg aspirin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GWU Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Related Publications (1)
Fallahi P, Katz R, Toma I, Li R, Reiner J, VanHouten K, Carpio L, Marshall L, Lian Y, Bupp S, Fu SW, Rickles F, Leitenberg D, Lai Y, Weksler BB, Rebling F, Yang Z, McCaffrey TA. Aspirin insensitive thrombophilia: transcript profiling of blood identifies platelet abnormalities and HLA restriction. Gene. 2013 May 15;520(2):131-8. doi: 10.1016/j.gene.2013.02.032. Epub 2013 Feb 27.
PMID: 23454623RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Timothy McCaffrey
- Organization
- George Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Reiner, MD
GWU Medical Faculty
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 27, 2011
Study Start
December 1, 2007
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
December 16, 2013
Results First Posted
December 16, 2013
Record last verified: 2011-01