AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction

Platelet Dysfunction Due to Aspirin Ingestion Clinical Trial

Official title:

AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915407
• Other study ID #: AGD 051
• 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

• Blood Platelet Disorders
• Platelet Dysfunction Due to Aspirin Ingestion

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