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AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01915407
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Aggredyne, Inc.

Brief Summary:
To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.

Condition or disease
Platelet Dysfunction Due to Aspirin Ingestion

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013



Primary Outcome Measures :
  1. Platelet Activity Index (PAI) before and after ingestion of aspirin [ Time Frame: 2 - 30 hours post aspirin ingestion ]
    PAI is the proprietary reporting unit of the Aggreguide. It is related to the amount of platelet aggregation in the sample of whole blood.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
aspirin naïve subjects over 18
Criteria

Inclusion Criteria:

  • over 18

Exclusion Criteria:

  • on aspirin in prior week
  • medical history of platelet disorders
  • contraindications to aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915407


Locations
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United States, Texas
Aggredyne, Inc.
Houston, Texas, United States, 77099
Sponsors and Collaborators
Aggredyne, Inc.
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Responsible Party: Aggredyne, Inc.
ClinicalTrials.gov Identifier: NCT01915407    
Other Study ID Numbers: AGD 051
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases