NCT03111420

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

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

January 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 21, 2019

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

April 2, 2017

Last Update Submit

February 20, 2019

Conditions

Risk Factor, CardiovascularPlatelet Dysfunction Due to Drugs

Outcome Measures

Primary Outcomes (1)

  • Change in Platelet Activity Index (PAI)

    Platelet reactivity measurement using A-100 ADP assay

    Baseline, day 1, day 7

Study Arms (3)

Clopidogrel

EXPERIMENTAL

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 inhibitorDevice: Platelet function test

Prasugrel

EXPERIMENTAL

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 inhibitorDevice: Platelet function test

Ticagrelor

EXPERIMENTAL

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 inhibitorDevice: Platelet function test

Interventions

P2Y12 inhibitorDRUG

Administration of P2Y12 inhibitor antiplatelet therapy

Also known as: clopidogrel, prasugrel, ticagrelor
ClopidogrelPrasugrelTicagrelor
Platelet function testDEVICE

Blood is drawn for testing of platelet aggregation activity

Also known as: AggreGuide A-100 ADP assay
ClopidogrelPrasugrelTicagrelor

Eligibility Criteria

Age22 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34143384DERIVED

MeSH Terms

Interventions

ClopidogrelPrasugrel HydrochlorideTicagrelorPlatelet Function Tests

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperazinesAdenosinePurine NucleosidesPurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Phil Speros

    Aggredyne, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Platelet function test results are not provided to the participant, care provider, or investigator
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2017

First Posted

April 12, 2017

Study Start

January 9, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 21, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share