Genotypic and Phenotypic Correlates of Resistance to Aspirin

Platelet Dysfunction Due to Aspirin Clinical Trial

— ARSENAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361620
• Other study ID #: AR2011
• 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

• Blood Platelet Disorders
• Platelet Dysfunction Due to Aspirin

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