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NCT00767572 · ClinicalTrials.gov registry record · Phase 4
Statins and Endothelial Function in Patients With Coarctation of the Aorta
A Phase 4 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00767572: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.
NCT00767572 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00767572, a Phase 4 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Coarctation of the aorta (CoA) accounts for approximately 8% of all congenital heart problems. Patients with CoA are well known to have an increased rates of early heart disease, high blood pressure, heart failure and stroke. Abnormal arterial function (dilation and constriction of the blood vessels) has been observed in these patients and likely contributes to the increased risk of cardiovascular problems. However, therapies targeted at improving arterial function have not been investigated in this population. Statin therapy (cholesterol medicines like Lipitor) have been studied in other subgroups of patients with abnormal arterial function and has shown benefit in improving arterial function and reducing risk of cardiovascular problems. The investigators hypothesize that patients with CoA have abnormal arterial function leading to increased cardiovascular risk. We further hypothesize that statin therapy may improve this problem. We plan to compile a complete database of information regarding these patients cardiovascular health and propose to then examine the effect of atorvastatin (Lipitor) on arterial function as measured by changes in arm arterial function tests.
Primary Outcome
Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.
Interventions
- DRUG atorvastatin
- DRUG Sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
Why NCT00767572 stopped before completion
NCT00767572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which atorvastatin is the first listed.
NCT00767572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00767572 about?
NCT00767572 is a clinical study titled "Statins and Endothelial Function in Patients With Coarctation of the Aorta". Coarctation of the aorta (CoA) accounts for approximately 8% of all congenital heart problems. Patients with CoA are well known to have an increased rates of early heart disease, high blood pressure, heart failure and stroke. Abnormal arterial function (dilation and constriction of the blood vessels...
What is the current status of trial NCT00767572?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2008-08. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00767572?
The interventions under investigation include: atorvastatin (DRUG), Sugar pill (DRUG).
Who is sponsoring clinical trial NCT00767572?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00767572's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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