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Completed

NCT Number: NCT03111420

Study of AggreGuide A-100 (ADP) Assay

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

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Key information

Conditions

Risk Factor, Cardiovascular Platelet Dysfunction Due to Drugs

Age range

22 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P2Y12 inhibitor

Drug

Administration of P2Y12 inhibitor antiplatelet therapy

Other names: clopidogrel, prasugrel, ticagrelor

Platelet function test

Device

Blood is drawn for testing of platelet aggregation activity

Other names: AggreGuide A-100 ADP assay

Primary outcomes

  1. Change in Platelet Activity Index (PAI)

    Time frame: Baseline, day 1, day 7

    Platelet reactivity measurement using A-100 ADP assay

Sponsors and collaborators

Lead sponsor

Aggredyne, Inc.

Industry

Registry information

Official study title

Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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