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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01361620
Other study ID # AR2011
Secondary ID
Status Completed
Phase N/A
First received May 25, 2011
Last updated October 29, 2013
Start date December 2007
Est. completion date April 2011

Study information

Verified date January 2011
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Description:

Not desired


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
aspirin
aspirin 81mg, 7-10 days

Locations

Country Name City State
United States GWU Medical Faculty Associates Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & 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 p — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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Completed NCT05604118 - Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin N/A