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Study of AggreGuide A-100 (ADP) Assay

Sponsor
Aggredyne, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03111420
Collaborator
(none)
280
Enrollment
3
Arms
16.7
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: P2Y12 inhibitor
  • Device: Platelet function test
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Platelet function test results are not provided to the participant, care provider, or investigator
Primary Purpose:
Diagnostic
Official Title:
Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs
Actual Study Start Date :
Jan 9, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

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:
  • clopidogrel
  • prasugrel
  • ticagrelor

    • 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:
  • clopidogrel
  • prasugrel
  • ticagrelor

    • 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:
  • clopidogrel
  • prasugrel
  • ticagrelor

    • Device: Platelet function test
    Blood is drawn for testing of platelet aggregation activity
    Other Names:
  • AggreGuide A-100 ADP assay

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Platelet Activity Index (PAI) [Baseline, day 1, day 7]

      Platelet reactivity measurement using A-100 ADP assay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aggredyne, Inc.

    Investigators

    • Study Director: Phil Speros, Aggredyne, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aggredyne, Inc.
    ClinicalTrials.gov Identifier:
    NCT03111420
    Other Study ID Numbers:
    • VAL-0085
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Feb 21, 2019
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Blood Platelet Disorders
    Clopidogrel
    Ticagrelor
    Prasugrel Hydrochloride

    Study Results

    No Results Posted as of Feb 21, 2019