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Study of AggreGuide A-100 (ADP) Assay

Primary Purpose

Risk Factor, Cardiovascular, Platelet Dysfunction Due to Drugs

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
P2Y12 inhibitor
Platelet function test
Sponsored by
Aggredyne, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Risk Factor, Cardiovascular

Eligibility Criteria

22 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Clopidogrel

    Prasugrel

    Ticagrelor

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Platelet Activity Index (PAI)
    Platelet reactivity measurement using A-100 ADP assay

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2017
    Last Updated
    February 20, 2019
    Sponsor
    Aggredyne, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03111420
    Brief Title
    Study of AggreGuide A-100 (ADP) Assay
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 9, 2017 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Aggredyne, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Risk Factor, Cardiovascular, Platelet Dysfunction Due to Drugs

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Platelet function test results are not provided to the participant, care provider, or investigator
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clopidogrel
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Prasugrel
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Ticagrelor
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    P2Y12 inhibitor
    Other Intervention Name(s)
    clopidogrel, prasugrel, ticagrelor
    Intervention Description
    Administration of P2Y12 inhibitor antiplatelet therapy
    Intervention Type
    Device
    Intervention Name(s)
    Platelet function test
    Other Intervention Name(s)
    AggreGuide A-100 ADP assay
    Intervention Description
    Blood is drawn for testing of platelet aggregation activity
    Primary Outcome Measure Information:
    Title
    Change in Platelet Activity Index (PAI)
    Description
    Platelet reactivity measurement using A-100 ADP assay
    Time Frame
    Baseline, day 1, day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Phil Speros
    Organizational Affiliation
    Aggredyne, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34143384
    Citation
    Gurbel PA, Tantry US, Bliden KP, Fisher R, Sukavaneshvar S, Dahlen J, Speros PC. Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists. J Thromb Thrombolysis. 2021 Jul;52(1):272-280. doi: 10.1007/s11239-021-02498-0. Epub 2021 Jun 18.
    Results Reference
    derived

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    Study of AggreGuide A-100 (ADP) Assay

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