Study of AggreGuide A-100 (ADP) Assay

Risk Factor, Cardiovascular Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111420
• Other study ID #: VAL-0085
• Status: Completed
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: June 2018

Study information

• Verified date: May 2018
• Source: Aggredyne, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Platelet Dysfunction Due to Drugs
• Risk Factor, Cardiovascular

Intervention

Drug:
• P2Y12 inhibitor
Administration of P2Y12 inhibitor antiplatelet therapy

Device:
• Platelet function test
Blood is drawn for testing of platelet aggregation activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aggredyne, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Platelet Activity Index (PAI)	Platelet reactivity measurement using A-100 ADP assay	Baseline, day 1, day 7