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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01915407
Other study ID # AGD 051
Secondary ID
Status Completed
Phase N/A
First received July 30, 2013
Last updated August 1, 2013
Start date April 2013
Est. completion date July 2013

Study information

Verified date August 2013
Source Aggredyne, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18

Exclusion Criteria:

- on aspirin in prior week

- medical history of platelet disorders

- contraindications to aspirin

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Aggredyne, Inc. Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Aggredyne, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Platelet Activity Index (PAI) before and after ingestion of aspirin PAI is the proprietary reporting unit of the Aggreguide. It is related to the amount of platelet aggregation in the sample of whole blood. 2 - 30 hours post aspirin ingestion No