Platelet Activation Testing Before/After Anti-platelet TherapyEarly Phase 1NCT04822363
The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry
A Early Phase 1 study testing Aspirin and Clopidogrel in people with Platelet Activation Testing Before/After Anti-platelet Therapy and Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Activation Testing Before/After Anti-platelet Therapy, Healthy
- What is being tested?
- Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 30 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
- Being tested
- Aspirin, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B
ClopidogrelDrug
Arms C and E
| Study group | Role | What they receive |
|---|---|---|
| Group A: Healthy | Experimental | Low Dose Aspirin - 81mg daily for 7 days Receives: Drug: Aspirin |
| Group B: Healthy | Experimental | High Dose Aspirin - 325mg daily for 7 days Receives: Drug: Aspirin |
| Group C: Healthy | Experimental | Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days Receives: Drug: Clopidogrel |
| Group D: Obese | Experimental | Low Dose Aspirin - 81mg daily for 7 days Receives: Drug: Aspirin |
| Group E: Obese | Experimental | Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry
Sensitivity of pDrp1 assay for platelet inhibition at day 5
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start20 Aug 2021
- Primary completion9 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Activation Testing Before/After Anti-platelet TherapyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Rushad Patell, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822363
- Sponsor's protocol ID
- 2021-P-000134
- Status last verified
- Jan 2025
- First submitted
- 26 Mar 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry
- ClinicalTrials.gov ID
- NCT04822363
- Acronym / sponsor ID
- 2021-P-000134
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: Healthy | Experimental | Drug: AspirinLow Dose Aspirin - 81mg daily for 7 days |
| Group B: Healthy | Experimental | Drug: AspirinHigh Dose Aspirin - 325mg daily for 7 days |
| Group C: Healthy | Experimental | Drug: ClopidogrelClopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days |
| Group D: Obese | Experimental | Drug: AspirinLow Dose Aspirin - 81mg daily for 7 days |
| Group E: Obese | Experimental | Drug: ClopidogrelClopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinLow dose aspirin in Arms A and D and High Dose Aspirin in Arm B | Drug | Group A: Healthy, Group B: Healthy, Group D: Obese |
| ClopidogrelArms C and E | Drug | Group C: Healthy, Group E: Obese |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin and Clopidogrel in people with Platelet Activation Testing Before/After Anti-platelet Therapy and Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.