Study of AggreGuide A-100 (ADP) Assay

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aggredyne, Inc.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

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.