New blood test could improve how we monitor heart medications
NCT ID NCT04822363
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new blood test (pDrp1 assay) to measure platelet activity in 112 healthy and severely obese volunteers taking aspirin or clopidogrel. The goal was to see if the new test is as accurate as the current standard test (light transmission aggregometry). Researchers also looked at how the drugs work over time. The study is complete, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin and Clopidogrel
- What this could lead to
- If successful, this could provide a simpler, faster blood test to measure how well antiplatelet drugs work, helping doctors tailor treatments.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. The new test may not prove accurate enough or may not work in real-world clinical settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
112 people
The number who actually took part.
- Started
-
Aug 2021
- Finished
-
Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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