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Nonsteroidal Anti-inflammatory Drug

Aspirin 81 mg for Non-alcoholic Fatty Liver Disease

Phase 1 & 2
Waitlist Available
Led By Tracey G Simon, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether or not aspirin can help reduce the amount of fat in the liver for people with nonalcoholic fatty liver disease, a condition that affects 30% of adults in the US.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent intrahepatic lipid content, quantified by 1H-MRS
Secondary outcome measures
Concentrations of circulating bioactive lipid mediators

Side effects data

From 2011 Phase 2 & 3 trial • 93 Patients • NCT01586975
6%
Nose bleeds
3%
GI bleeding
3%
Clinical Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin 81 mg
Aspirin >300 mg
Clopidogrel 75 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AspirinExperimental Treatment1 Intervention
Low-dose (81mg) aspirin tablets
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 81 mg
2007
Completed Phase 4
~810

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,275 Total Patients Enrolled
14 Trials studying Non-alcoholic Fatty Liver Disease
767 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Tracey G Simon, MD, MPHPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

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

Does this clinical trial cater to participants aged 85 or over?

"According to the listed parameters, this trial is recruiting adults aged 18-69. Additionally, there are 48 studies open for minors and 476 trials with participants over 65 years of age."

Answered by AI

Are there still available slots for participants in this research?

"According to the clinicaltrials.gov portal, this experimental procedure is actively seeking participants and was first launched on September 12th 2019 before being updated most recently on February 23rd 2022."

Answered by AI

Do I fulfill the criteria to participate in this research?

"This trial seeks to recruit 80 adults between the ages of eighteen and sixty-nine that are diagnosed with nonalcoholic fatty liver. To be considered a suitable candidate, they must present hepatic steatosis supported either through imaging or biopsy without other causes of fat accumulation in the liver or excessive alcohol consumption. Additionally, early stage fibrosis (F2) needs to have been confirmed via recent biopsy or elastography/Fibroscan test; if not already performed then one will take place during screening visit."

Answered by AI

What is the maximum capacity for participants in this research endeavor?

"Affirmative, according to clinicaltrials.gov the trial is still actively recruiting patients. This investigation was first posted on September 12th 2019 and most recently updated on February 23rd 2022 - with a total of 80 participants needed from 1 medical centre."

Answered by AI

What indications is Aspirin 81 mg usually prescribed for?

"Aspirin 81 mg is the preferred intervention for percutaneous coronary interventions (PCI). It can also be utilized to alleviate inflammation, neck pain and other minor dental issues."

Answered by AI

Is this research a pioneering endeavor?

"Since 2005, the drug Aspirin 81 mg has gone through a rigorous clinical trial process. The initial study was conducted by Abbott in 15480 and eventually led to Phase 4 approval for this medication. At present, 168 studies are being done with Aspirin 81 mg throughout 1398 cities and 57 nations worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Massachusetts
Arkansas
How old are they?
18 - 65
65+
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~14 spots leftby Apr 2025