Study of AggreGuide A-100 (ADP) Assay

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03111420

Enrollment

280

Registered

2017-04-12

Start date

2017-01-09

Completion date

2018-06-30

Last updated

2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Factor, Cardiovascular, Platelet Dysfunction Due to Drugs

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.

Interventions

DRUGP2Y12 inhibitor

Administration of P2Y12 inhibitor antiplatelet therapy

DEVICEPlatelet function test

Blood is drawn for testing of platelet aggregation activity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Platelet function test results are not provided to the participant, care provider, or investigator

Eligibility

Sex/Gender

ALL

Age

22 Years to 74 Years

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026