Genotypic and Phenotypic Correlates of Resistance to Aspirin (ARSENAL)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by George Washington University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

George Washington University

ClinicalTrials.gov Identifier:

NCT01361620

First received: May 25, 2011

Last updated: May 26, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 25, 2011
Last Updated Date	May 26, 2011
Start Date ^ICMJE	December 2007
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 26, 2011)	Identify genomic markers associated with aspirin resistance [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01361620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Genotypic and Phenotypic Correlates of Resistance to Aspirin
Official Title ^ICMJE	Genotypic and Phenotypic Correlates of Resistance to Anti-platelet Actions of Aspirin in an At-risk Patient Population and in the General Population
Brief Summary	The study seeks to identify genomic markers associated with aspirin resistance.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Aspirin Resistance
Intervention ^ICMJE	Drug: aspirin aspirin 81mg, 7-10 days
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	190
Completion Date	Not Provided
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01361620
Other Study ID Numbers ^ICMJE	AR2011
Has Data Monitoring Committee	No
Responsible Party	Jonathan Reiner, MD, GWU Medical Faculty Associates
Study Sponsor ^ICMJE	George Washington University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	George Washington University
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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