Status:
RECRUITING
The Accuracy of a Novel Platelet Activity Assay in Humans on Antiplatelet Agents: Pharmacodynamics and Comparison with Light Transmission Aggregometry
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Conditions:
Platelet Activation Testing Before/after Anti-platelet Therapy
Healthy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 clop...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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)
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04822363
Start Date
August 20 2021
End Date
April 1 2026
Last Update
January 23 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215