NCT04822363

The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test a novel diagnostic immunoassay of platelet function and compare it to the current gold standard platelet function assay by testing the response to aspirin and clopidogrel in a group of healthy volunteers and severely obese individuals and comparing the accuracy of the two tests. The secondary goals will be to evaluate the pharmacodynamic parameters of the antiplatelet agents across the two testing modalities and refine the cutoffs used for the novel assay.

Conditions

• Platelet Activation Testing Before/After Anti-platelet Therapy
• Healthy

Interventions

Type	Name	Description
DRUG	Aspirin	Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B
DRUG	Clopidogrel	Arms C and E

Timeline

• Start date: 2021-08-20
• Primary completion: 2025-05-09
• Completion: 2025-06-30
• First posted: 2021-03-30
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study