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Aspirin Responsiveness in Women at Risk for Cardiac Events

NCT ID: NCT00818337

Last Updated: 2012-12-04

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

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.

Detailed Description

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Conditions

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Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aspirin 81mg

Resistant

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily

Interventions

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Aspirin

Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women at least 19 years old
* Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
* Able and willing to provide informed consent

Exclusion Criteria

* Pregnancy or breastfeeding
* Known CHD
* Currently taking clopidogrel or ticlopidine
* Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
* Allergy or hypersensitivity to salicylates
* Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
* Currently participating in another investigational drug or device study
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Cardiac Center at Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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08-14888

Identifier Type: -

Identifier Source: org_study_id