NCT01915407

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

July 30, 2013

Last Update Submit

August 1, 2013

Conditions

Platelet Dysfunction Due to Aspirin Ingestion

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

aspirin naïve subjects over 18

You may qualify if:

  • over 18

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aggredyne, Inc.

Houston, Texas, 77099, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 2, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

US(1)