Clinical Trial: Study of AggreGuide A-100 (ADP) Assay

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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. Study subjects will have measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy.

Detailed Summary:
Sponsor: Aggredyne, Inc.

Current Primary Outcome:

• Platelet Activity Index (PAI) [ Time Frame: Baseline ]
  Platelet reactivity measurement using A-100 ADP assay
• Platelet Activity Index (PAI) [ Time Frame: Day 1 ]
  Platelet reactivity measurement using A-100 ADP assay
• Platelet Activity Index (PAI) [ Time Frame: Day 7 ]
  Platelet reactivity measurement using A-100 ADP assay

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Aggredyne, Inc.

Dates:
Date Received: April 2, 2017
Date Started: January 9, 2017
Date Completion: April 30, 2017
Last Updated: April 7, 2017
Last Verified: April 2017