Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
837 Previous Clinical Trials
13,010,147 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,529 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,751 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am able to follow the study's requirements as judged by the researcher.I am 18 years old or older.I am not pregnant and agree to use birth control during the study.I have had a stomach bleed in the past 2 years or a stomach ulcer in the past year.I have been diagnosed with cirrhosis or active cancer.I have had a bleeding stroke in my lifetime.I haven't taken aspirin, blood thinners, or similar drugs in the last 2 weeks.My BMI is either below 30 or above 35, depending on the group I am in.You have had an allergic reaction to aspirin or clopidogrel in the past.I have not been hospitalized or had surgery in the last 6 months.I haven't taken specific antibiotics, heart drugs, antidepressants, antihistamines, over-the-counter drugs, or supplements in the last 2 weeks.I or my family have a history of bleeding disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Group C: Healthy
- Group 2: Group A: Healthy
- Group 3: Group B: Healthy
- Group 4: Group D: Obese
- Group 5: Group E: Obese
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still places available in this research program for participants?
"The most recent information on clinicaltrials.gov affirms that this study is open for enrollment. This trial was first posted on 8/20/2021, and the 125 participants will be seen at a single site."
Answered by AI
What does the scientific community know about Aspirin's effects?
"Out of the 204 ongoing clinical trials investigating aspirin, 57 are in Phase 3. Most research is taking place in New Orleans, LA; however, there are 4146 total locations running these trials."
Answered by AI
Is this an innovative clinical trial?
"Since the year 2002, Aspirin has been under continual medical scrutiny. The first clinical trial took place that same year and was funded by Sanofi. Since the initial study in 2002, which had 413 participants, there have been 204 studies conducted in 62 different countries across 1462 cities."
Answered by AI
How many people are anticipated to join this clinical trial?
"Yes, the most recent data from clinicaltrials.gov suggests that this study is still open to new participants. The trial was established on 8/20/2021 and updated as recently as 3/31/2022. They are looking for 125 volunteers at 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
New Hampshire
What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
The study looks very interesting for an aging obese person like myself.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger