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

NCT04822363 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 2021-P-000134
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry

  Sensitivity of pDrp1 assay for platelet inhibition at day 5

  5 days

Study Arms (5)

Group A: Healthy

EXPERIMENTAL

Low Dose Aspirin - 81mg daily for 7 days

Drug: Aspirin

Group B: Healthy

EXPERIMENTAL

High Dose Aspirin - 325mg daily for 7 days

Drug: Aspirin

Group C: Healthy

EXPERIMENTAL

Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days

Drug: Clopidogrel

Group D: Obese

EXPERIMENTAL

Low Dose Aspirin - 81mg daily for 7 days

Drug: Aspirin

Group E: Obese

EXPERIMENTAL

Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days

Drug: Clopidogrel

Interventions

Aspirin DRUG

Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B

Group A: Healthy; Group B: Healthy; Group D: Obese

Clopidogrel DRUG

Arms C and E

Group C: Healthy; Group E: Obese

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age
• Subject is willing to participate and provide informed consent
• Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator
• Groups A, B and C: BMI \< 30 kg/m2; Groups D and E: BMI ≥ 35 kg/m2
• Subjects must be age ≥ 18 years old
• Serum Creatinine \< 1.5 mg/dL
• Platelet count ≥ 150 K/uL
• Hematocrit ≥ 38%

You may not qualify if:

• Pregnant. If female of child-bearing age, negative urinary pregnancy test required at time of enrollment. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant she should inform her treating physician immediately.
• Established diagnosis of cirrhosis or active cancer
• History of allergy to aspirin or clopidogrel
• Any history of taking aspirin, antiplatelet drugs, NSAIDS, cyclooxygenase (COX)-2 inhibitors, warfarin, low-molecular weight heparin, thrombolytic agents, or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors) within 2 weeks prior to enrollment. (Refer to appendix)
• Use of certain antibiotics, cardiovascular drugs, lipid-lowering agents, antidepressants, antihistamines, non-prescription drugs, and supplements within the past 2 weeks. (Refer to appendix)
• Any major illness requiring hospitalization or surgery in the previous six months.
• Personal history of gastrointestinal bleed in the last 24 months or diagnosis of peptic ulcer disease in the last 12 months
• Lifetime personal history of hemorrhagic stroke.
• Personal or family history of bleeding diatheses, including hemophilias, von Willebrand's disease, Bernard-Soulier syndrome, or Glanzmann thrombasthenia (unless otherwise confirmed not present in study subject)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: August 20, 2021
• Primary Completion: May 9, 2025
• Study Completion: June 30, 2025
• Last Updated: January 22, 2026

Record last verified: 2025-01

Locations

US (1)