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Antiplatelet Agent

Platelet Activity Assay for Blood-Thinner Monitoring in Obese Individuals

Phase < 1
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is ≥18 years of age
Subjects must be age ≥ 18 years old
Must not have
Established diagnosis of cirrhosis or active cancer
Lifetime personal history of hemorrhagic stroke.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Summary

This trial tests a new way to measure how well blood-thinning medication is working in people who are obese.

Who is the study for?
This trial is for adults over 18 who are healthy or severely obese (BMI <30 or ≥35 kg/m2), with normal kidney function, blood platelet count, and hematocrit levels. It's not for pregnant women, those with recent drug use that affects blood clotting, major illness/surgery history, gastrointestinal bleeds/ulcers, hemorrhagic stroke history, or bleeding disorders.
What is being tested?
The study tests a new platelet activity assay against the standard test by measuring responses to aspirin and clopidogrel in volunteers. It aims to determine the accuracy of this novel assay and refine its parameters compared to traditional methods.
What are the potential side effects?
Aspirin and Clopidogrel can cause side effects like increased risk of bleeding, bruising easily, upset stomachs or heartburn. Serious but rare side effects include severe bleeding or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with cirrhosis or active cancer.
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I have had a bleeding stroke in my lifetime.
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I have not been hospitalized or had surgery in the last 6 months.
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I haven't taken specific antibiotics, heart drugs, antidepressants, antihistamines, over-the-counter drugs, or supplements in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry

Trial Design

5Treatment groups
Experimental Treatment
Group I: Group E: ObeseExperimental Treatment1 Intervention
Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days
Group II: Group D: ObeseExperimental Treatment1 Intervention
Low Dose Aspirin - 81mg daily for 7 days
Group III: Group C: HealthyExperimental Treatment1 Intervention
Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days
Group IV: Group B: HealthyExperimental Treatment1 Intervention
High Dose Aspirin - 325mg daily for 7 days
Group V: Group A: HealthyExperimental Treatment1 Intervention
Low Dose Aspirin - 81mg daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Clopidogrel
2010
Completed Phase 4
~9160

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,929,979 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,082 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,386 Total Patients Enrolled

Media Library

Aspirin (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04822363 — Phase < 1
Platelet Function Testing Research Study Groups: Group C: Healthy, Group A: Healthy, Group B: Healthy, Group D: Obese, Group E: Obese
Platelet Function Testing Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT04822363 — Phase < 1
Aspirin (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04822363 — Phase < 1
~31 spots leftby Sep 2025
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