Study of AggreGuide A-100 (ADP) Assay

AggreDyne

Status: Completed

Conditions: Platelet Dysfunction Due to Drugs; Risk Factor, Cardiovascular

Treatments: Drug: P2Y12 inhibitor; Device: Platelet function test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03111420

VAL-0085

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 22 to 74 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 3 patient groups

Clopidogrel

Experimental group

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.

Treatment:

Device: Platelet function test

Drug: P2Y12 inhibitor

Prasugrel

Experimental group

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.

Treatment:

Device: Platelet function test

Drug: P2Y12 inhibitor

Ticagrelor

Experimental group

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.

Treatment:

Device: Platelet function test

Drug: P2Y12 inhibitor