Study of AggreGuide A-100 (ADP) Assay

Study Overview
=================
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.

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

Conditions
-----------------
Risk Factor, Cardiovascular, Platelet Dysfunction Due to Drugs

Intervention / Treatment
-----------------
* Drug: P2Y12 inhibitor
* Device: Platelet function test


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel<br>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 inhibitor<br>* Administration of P2Y12 inhibitor antiplatelet therapy<br>* Other names: ticagrelor;Device: Platelet function test<br>* Blood is drawn for testing of platelet aggregation activity<br>* Other names: AggreGuide A-100 ADP assay;|
| Experimental: Prasugrel<br>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 inhibitor<br>* Administration of P2Y12 inhibitor antiplatelet therapy<br>* Other names: ticagrelor;Device: Platelet function test<br>* Blood is drawn for testing of platelet aggregation activity<br>* Other names: AggreGuide A-100 ADP assay;|
| Experimental: Ticagrelor<br>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 inhibitor<br>* Administration of P2Y12 inhibitor antiplatelet therapy<br>* Other names: ticagrelor;Device: Platelet function test<br>* Blood is drawn for testing of platelet aggregation activity<br>* Other names: AggreGuide A-100 ADP assay;|

What is the study measuring?
-----------------
Primary Outcome Measures

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