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Genotypic and Phenotypic Correlates of Resistance to Aspirin

NCT ID: NCT01361620

Last Updated: 2013-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Not desired

Conditions

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Platelet Dysfunction Due to Aspirin

Keywords

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genomic markers aspirin resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Aspirin

All subjects took 7-10 days of 81 mg aspirin

Group Type OTHER

aspirin

Intervention Type DRUG

aspirin 81mg, 7-10 days

Interventions

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aspirin

aspirin 81mg, 7-10 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Reiner, MD

Role: PRINCIPAL_INVESTIGATOR

GWU Medical Faculty

Locations

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GWU Medical Faculty Associates

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23454623 (View on PubMed)

Other Identifiers

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AR2011

Identifier Type: -

Identifier Source: org_study_id