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Nonsteroidal Anti-inflammatory Drug

Aspirin Dosing for Obesity

Phase 4
Recruiting
Led By Sean Heffron, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 40 and 70 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9, week 12
Awards & highlights

Study Summary

This trial looks at the effects of aspirin and body weight on blood and neutrophils.

Who is the study for?
This trial is for non-smoking adults aged 40-70 who are not pregnant, don't have diabetes, bleeding/clotting disorders, immune deficiencies, or chronic inflammatory diseases. They shouldn't have had recent changes in statin drugs or surgeries affecting the stomach and must not be on certain medications including aspirin.Check my eligibility
What is being tested?
The study is testing how different doses of aspirin (81mg and 325mg) affect blood levels of substances that help resolve inflammation in obese individuals. It's a placebo-controlled study where participants will receive both doses and a placebo at different times without knowing which one they're getting.See study design
What are the potential side effects?
Aspirin can cause side effects like stomach pain, heartburn, nausea, increased risk of bleeding. Rarely it may lead to severe allergic reactions or worsening asthma symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 40 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 9, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 9, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Serum 15R-LXA4
Secondary outcome measures
Change in leukocyte expression of ALX/FPR2
Change in leukocyte expression of BLT1
Change in leukocyte expression of ERV1/ChemR23
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Aspirin 81mg, Then Aspirin 325mgExperimental Treatment2 Interventions
After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.
Group II: Aspirin 325mg, Then Aspirin 81mgExperimental Treatment2 Interventions
After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 325mg
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,601 Total Patients Enrolled
26 Trials studying Obesity
10,995 Patients Enrolled for Obesity
Sean Heffron, MDPrincipal InvestigatorNYU Langone Health

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04697719 — Phase 4
Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697719 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a pioneering initiative in terms of research?

"Currently, there are 168 active trials for Aspirin 325mg across 57 nations and 1398 cities. The initial study pertaining to this medication was conducted in 2005 by Abbott which included 15480 participants. After the success of Phase 4 drug approval stage, 508 other clinical studies were launched in following years."

Answered by AI

To what extent may taking Aspirin 325mg be hazardous for individuals?

"The safety of Aspirin 325mg is rated 3 out of 3 due to it being approved as a therapeutic treatment following Phase 4 trials."

Answered by AI

To what end is Aspirin 325mg routinely prescribed?

"Aspirin 325mg is regularly prescribed to manage percutaneous coronary intervention (PCI). Aside from PCI, this dosage of aspirin can also be beneficial in alleviating inflammation, pain related to dental procedures, and neck discomfort."

Answered by AI

What is the total enrollment number for this research project?

"Affirmative. Clinicaltrials.gov houses information that indicates this medical trial, posted November 4th 2021, is actively seeking participants at a single site and requires 125 patients in total."

Answered by AI

Are there any vacancies in this medical trial for participants?

"Affirmative. According to the information hosted on clinicaltrials.gov, recruitment for this medical trial is in progress since its publication date of November 4th 2021 and most recent modification at March 8th 2022."

Answered by AI

Is this research protocol open to those aged eighty-five and older?

"Those aged between 40 and 70 are eligible for this trial."

Answered by AI

Can I take part in this trial?

"This medical trial is searching for 125 individuals between the ages of 40 and 70 who meet a certain weight requirement. Notably, applicants must be within the aforementioned age limit to qualify."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Body Weight, Aspirin Dose and Pro-resolving Mediators
2021. "Body Weight, Aspirin Dose and Pro-resolving Mediators". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04697719.
All > Aspirin > Durlaza
~27 spots leftby Jan 2025
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