Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Stopped early · Phase 4
Conditions studied: Fontan Procedure
In brief
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.
Key facts
- Study ID
- NCT02966002
- Run by
- University of Michigan
- People needed
- 9
- Starts
- 2016-04-01
- Expected to finish
- 2017-05-25
- Last updated by the study team
- 2018-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults who have Fontan repair of single ventricle
- Exclusion Criteria: Persons with the following history, conditions, or behavior will be excluded
- Active protein losing enteropathy within the past three years
- Congestive heart failure
- Active arrhythmias
- Taking Coumadin (Warfarin)
- Bleeding disorder
- Known esophageal varicies
- Consuming more than 10 alcoholic drinks per week.
- Pregnant
- Planning to become pregnant
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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