Study of AggreGuide A-100 (ADP) Assay

Not Applicable

Completed

• Conditions: Platelet Dysfunction Due to Drugs; Risk Factor, Cardiovascular
• Interventions: Drug: P2Y12 inhibitor; Device: Platelet function test

• Registration Number: NCT03111420
• Lead Sponsor: Aggredyne, Inc.

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.

Study Timeline

• Study Start: 2017-01-09
• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Status Verified: 2018-05
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	P2Y12 inhibitor	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.
Ticagrelor	Platelet function test	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.
Prasugrel	P2Y12 inhibitor	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.
Prasugrel	Platelet function test	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.
Clopidogrel	Platelet function test	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.
Ticagrelor	P2Y12 inhibitor	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.

Primary Outcome Measures

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