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Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Low-dose (81mg) aspirin tablets |
|
| Placebo | Placebo Comparator | Placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Intrahepatic Lipid Content, by 1H-MRS | Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Intrahepatic Lipid Content | Relative percentage point change in intrahepatic lipid content | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracey G Simon, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38502074 | Derived | Simon TG, Wilechansky RM, Stoyanova S, Grossman A, Dichtel LE, Lauer GM, Miller KK, Hoshida Y, Corey KE, Loomba R, Chung RT, Chan AT. Aspirin for Metabolic Dysfunction-Associated Steatotic Liver Disease Without Cirrhosis: A Randomized Clinical Trial. JAMA. 2024 Mar 19;331(11):920-929. doi: 10.1001/jama.2024.1215. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin | Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial. |
| FG001 | Placebo | Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin | Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial. |
| BG001 | Placebo | Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change in Intrahepatic Lipid Content, by 1H-MRS | Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS | Posted | Least Squares Mean | 95% Confidence Interval | Mean absolute percentage change | 6 months |
|
Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin | Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracey Simon | Massachusetts General Hospital | 617-724-2401 | tgsimon@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2019 | Mar 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo oral tablet | Drug | Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline hepatic lipid content (%) by 1H_MRS | Mean | Standard Deviation | percentage of hepatic lipid content |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Relative Change in Intrahepatic Lipid Content | Relative percentage point change in intrahepatic lipid content | Posted | Least Squares Mean | 95% Confidence Interval | Mean percentage point change | 6 months |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 12 |
| 40 |
| EG001 | Placebo | Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial. | 0 | 40 | 1 | 40 | 12 | 40 |
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgias | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgias | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Other infection | Infections and infestations | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Atherosclerosis | Cardiac disorders | Non-systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |