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NCT02112539 Clinical Trial

Aggreguide A-100 ADP Assay Evaluation

Platelet Aggregation Clinical Trial

Official title:
Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Effect of ADP Blocking Drugs on Platelet Aggregation on the AggreGuide A-100 Instrument

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02112539
Other study ID # Val 0072-B
Secondary ID
Status Completed
Phase N/A
First received April 10, 2014
Last updated April 2, 2017
Start date March 2014
Est. completion date August 2014

Study information
Verified date April 2017
Source Aggredyne, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is to characterize the AggreGuide ADP Assay's performance.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18-75

Exclusion Criteria:

- less than 60 kg

- on antiplatelet meds other than aspirin

- antiplatelet drugs contraindicated

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• platelet aggregation measurement

Locations
Country Name City State
United States Juno Research 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) PAI at baseline and after taking ADP blocking antiplatelet drugs. 1 week
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