Testing a new platelet activity test in healthy and obese individuals on antiplatelet medications

The Accuracy of a Novel Platelet Activity Assay in Humans on Antiplatelet Agents: Pharmacodynamics and Comparison with Light Transmission Aggregometry

This study is testing a new way to measure how well blood platelets work in healthy people and those who are obese while they take common heart medications to see if it gives more accurate results than the current method.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04822363 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate a novel diagnostic immunoassay for measuring platelet function and compare its accuracy against the established gold standard, light transmission aggregometry. Participants, including healthy volunteers and severely obese individuals, will be administered aspirin and clopidogrel to assess their platelet response. The study will also analyze pharmacodynamic parameters of these antiplatelet agents and refine the cutoff values for the new assay. The goal is to improve the accuracy of platelet activation testing in patients undergoing antiplatelet therapy.

Who should consider this trial

Good fit: Ideal candidates include healthy adults and severely obese individuals aged 18 and older who meet specific health criteria.

Not a fit: Patients with a history of allergy to aspirin or clopidogrel, or those with active cancer or cirrhosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of platelet function in patients on antiplatelet therapy, improving treatment outcomes.

How similar studies have performed: Other studies have shown promise in developing novel platelet function assays, but this specific approach is relatively novel.

Eligibility 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)

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Jeffrey Zwicker, MD

Conditions: Platelet Activation Testing Before/after Anti-platelet Therapy, Healthy