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This study was terminated due to inability to recruit sufficient patients.
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Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: aspirin | Experimental | 650 mg. Twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol | Change will be measured from baseline to retest after 8 weeks of treatment | 8 weeks |
| Change in HDL (High-Density Lipoprotein)-Cholesterol | Change will be measured from baseline to retest after 8 weeks of treatment | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| High Sensitivity CRP(C-Reactive Protein) | Change will be measured from baseline to retest after 8 weeks of treatment | 8 weeks |
| Quality of Life | The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status. |
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Inclusion Criteria:
Exclusion Criteria: Persons with the following history, conditions, or behavior will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Adam Lubert, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Aspirin | 650 mg. Twice a day for 8 weeks Aspirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Aspirin | 650 mg. Twice a day for 8 weeks Aspirin |
| 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 | Change in Total Cholesterol | Change will be measured from baseline to retest after 8 weeks of treatment | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
8 weeks
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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 | Intervention: Aspirin | 650 mg. Twice a day for 8 weeks Aspirin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloody Bowel Movement | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Lubert | University of Michigan | 734-764-5177 | luberta@med.umich.edu |
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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 | Nov 23, 2015 | Mar 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| 8 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| HDL Cholesterol | Mean | Standard Deviation | mg/dL |
|
| High Sensitivity C-Reactive Protein | Mean | Standard Deviation | mg/dL |
|
| Quality of Life | The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Change in HDL (High-Density Lipoprotein)-Cholesterol | Change will be measured from baseline to retest after 8 weeks of treatment | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
|
| Secondary | High Sensitivity CRP(C-Reactive Protein) | Change will be measured from baseline to retest after 8 weeks of treatment | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
|
| Secondary | Quality of Life | The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |