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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822363
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : April 1, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jeff Zwicker, Beth Israel Deaconess Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 20, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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




Primary Outcome Measures :
  1. Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry [ Time Frame: 5 days ]
    Sensitivity of pDrp1 assay for platelet inhibition at day 5



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822363


Contacts
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Contact: Jeffrey Zwicker, MD 617-667-9920 jzwicker@bidmc.harvard.edu
Contact: Pavania Elavalakanar, MSc 617-667-1903 pelavala@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jeffrey Zwicker, MD    617-667-9920    jzwicker@bidmc.harvard.edu   
Contact: Pavania Elavalakanar, MSc    617-667-1903    pelavala@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
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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: March 30, 2021    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents