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

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04822363
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 125
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 43.4
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Activation Testing Before/After Anti-platelet Therapy; Healthy	Drug: Aspirin; Drug: Clopidogrel	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry
• Actual Study Start Date: Aug 20, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: Healthy Low Dose Aspirin - 81mg daily for 7 days	Drug: Aspirin; Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B
Experimental: Group B: Healthy High Dose Aspirin - 325mg daily for 7 days	Drug: Aspirin; Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B
Experimental: Group C: Healthy Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days	Drug: Clopidogrel; Arms C and E
Experimental: Group D: Obese Low Dose Aspirin - 81mg daily for 7 days	Drug: Aspirin; Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B
Experimental: Group E: Obese Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days	Drug: Clopidogrel; Arms C and E

Outcome Measures

Primary Outcome Measures

1. Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry [5 days]

   Sensitivity of pDrp1 assay for platelet inhibition at day 5

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subject is ≥18 years of age

2. Subject is willing to participate and provide informed consent

3. Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator

4. Groups A, B and C: BMI < 30 kg/m2; Groups D and E: BMI ≥ 35 kg/m2

5. Subjects must be age ≥ 18 years old

6. Serum Creatinine < 1.5 mg/dL

7. Platelet count ≥ 150 K/uL

8. Hematocrit ≥ 38%

Exclusion Criteria:

1. 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.

2. Established diagnosis of cirrhosis or active cancer

3. History of allergy to aspirin or clopidogrel

4. 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)

5. Use of certain antibiotics, cardiovascular drugs, lipid-lowering agents, antidepressants, antihistamines, non-prescription drugs, and supplements within the past 2 weeks. (Refer to appendix)

6. Any major illness requiring hospitalization or surgery in the previous six months.

7. Personal history of gastrointestinal bleed in the last 24 months or diagnosis of peptic ulcer disease in the last 12 months

8. Lifetime personal history of hemorrhagic stroke.

9. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeff Zwicker, Attending Physician, Associate Professor, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04822363
• Other Study ID Numbers: 2021-P-000134
• First Posted: Mar 30, 2021
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aspirin; Clopidogrel

Study Results

No Results Posted as of Apr 1, 2022