Study of AggreGuide A-100 (ADP) Assay

February 20, 2019 updated by: Aggredyne, Inc.

Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs

Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has a history of cardiovascular disease OR

  • Subject has 2 or more cardiac risk factors:

    • Smoking
    • Hypertension
    • Hyperlipidemia
    • Family History of Heart Disease
    • Post-menopausal female
    • Diabetes
    • Obesity (BMI > 30)
    • Sedentary lifestyle

Exclusion Criteria:

Taken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clopidogrel

Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.

Loading dose day 1. Maintenance dose over subsequent 7 days.
Drug: P2Y12 inhibitor
Administration of P2Y12 inhibitor antiplatelet therapy
Other Names:
  • ticagrelor
  • clopidogrel
  • prasugrel
Device: Platelet function test
Blood is drawn for testing of platelet aggregation activity
Other Names:
  • AggreGuide A-100 ADP assay
Experimental: Prasugrel

Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.

Loading dose day 1. Maintenance dose over subsequent 7 days.
Drug: P2Y12 inhibitor
Administration of P2Y12 inhibitor antiplatelet therapy
Other Names:
  • ticagrelor
  • clopidogrel
  • prasugrel
Device: Platelet function test
Blood is drawn for testing of platelet aggregation activity
Other Names:
  • AggreGuide A-100 ADP assay
Experimental: Ticagrelor

Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.

Loading dose day 1. Maintenance dose over subsequent 7 days.
Drug: P2Y12 inhibitor
Administration of P2Y12 inhibitor antiplatelet therapy
Other Names:
  • ticagrelor
  • clopidogrel
  • prasugrel
Device: Platelet function test
Blood is drawn for testing of platelet aggregation activity
Other Names:
  • AggreGuide A-100 ADP assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Platelet Activity Index (PAI)
Time Frame: Baseline, day 1, day 7
Platelet reactivity measurement using A-100 ADP assay
Baseline, day 1, day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aggredyne, Inc.

Investigators

  • Study Director: Phil Speros, Aggredyne, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

April 2, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAL-0085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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