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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Mar 26, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new test to measure how well platelets, which are tiny blood cells that help with clotting, respond to two common medications: aspirin and clopidogrel. Researchers want to see how accurate this new test is compared to the standard test currently used. They are inviting healthy volunteers, as well as those who are severely obese, to participate in the study. The goal is to better understand how these medications work in the body and to refine the new test to improve its effectiveness.

To be eligible for the trial, participants need to be at least 18 years old and willing to give their consent to join. They should also meet certain health criteria, such as having a specific body mass index (BMI) and certain blood test results. Participants can expect to undergo tests to check their platelet function before and after taking the medications. It’s important to note that individuals with certain health conditions, a history of bleeding disorders, or those taking specific medications recently may not be able to participate. This study aims to provide valuable information that could help improve platelet testing in the future.

Gender

ALL

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)