Study of AggreGuide A-100 (ADP) Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aggreguide A-100 ADP Assay Evaluation

NCT02112539

Platelet Aggregation ADP Blockers

COMPLETED

Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

NCT05730114

Cardiac Arrest Myocardial Infarction Extracorporeal Membrane Oxygenation +1 more

UNKNOWN

High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay

NCT02699008

Acute Coronary Syndrome

COMPLETED NA

The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry

NCT04822363

Platelet Activation Testing Before/After Anti-platelet Therapy Healthy

COMPLETED EARLY_PHASE1

Platelet Reactivity And Clinical ThrombotIC Events Study

NCT03525145

Acute Coronary Syndrome Antiplatelet Therapy Platelet Reactivity

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Risk Factor, Cardiovascular Platelet Dysfunction Due to Drugs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

P2Y12 inhibitor

Intervention Type DRUG

Administration of P2Y12 inhibitor antiplatelet therapy

Platelet function test

Intervention Type DEVICE

Blood is drawn for testing of platelet aggregation activity

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.

Group Type EXPERIMENTAL

P2Y12 inhibitor

Intervention Type DRUG

Administration of P2Y12 inhibitor antiplatelet therapy

Platelet function test

Intervention Type DEVICE

Blood is drawn for testing of platelet aggregation activity

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.

Group Type EXPERIMENTAL

P2Y12 inhibitor

Intervention Type DRUG

Administration of P2Y12 inhibitor antiplatelet therapy

Platelet function test

Intervention Type DEVICE

Blood is drawn for testing of platelet aggregation activity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

P2Y12 inhibitor

Administration of P2Y12 inhibitor antiplatelet therapy

Intervention Type DRUG

Platelet function test

Blood is drawn for testing of platelet aggregation activity

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

clopidogrel prasugrel ticagrelor AggreGuide A-100 ADP assay

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes