A Phase 4 interventional study of atorvastatin and Sugar pill in Coarctation of the Aorta, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-14.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Prevention
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.
The study design is a randomized double-blind cross over clinical trial. Patients who meet inclusion criteria and no exclusion criteria will be enrolled. They will undergo a baseline cardiovascular assessment including echocardiography, magnetic resonance imaging or magnetic resonance angiography (MRI/MRA), serum blood samples, brachial artery reactivity testing, and carotid intimal media thickness testing. Once they have completed their baseline testing, they will be randomized to either atorvastatin 80mg or placebo. They will complete 12 weeks of therapy and return at the end of 12 weeks to have a repeat brachial artery study and serum studies. There will then be a four week washout period where they take no medication. They will return for a follow up visit at the end of that four week period for repeat baseline brachial artery testing and serum studies. They then will be assigned to the opposite agent they were on previously (so if they originally were on placebo they switch to atorvastatin and vice versa). They will complete another 12 weeks of therapy and return at the end for a final brachial artery study and blood testing.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
Drug: atorvastatin
See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
Drug: Sugar pill
Atorvastatin 80mg daily vs. placebo daily X 12 weeks, then 4 week washout period, then cross over groups to complete another 12 weeks. (Total study time is 28 weeks (12+4+12)
Also known as: Lipitor
atorvastatin 80mg daily vs. placebo daily X 12 weeks, then 4 week washout, then cross over groups X 12 weeks. Total study time is 28weeks (12+4+12).
Also known as: placebo
Pre-post Change in Brachial Artery Reactivity
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.
Time frame: Baseline, 12 weeks
Patients were recruited from the UCSF Adult Congenital Heart Disease Clinic between July 2008 and July 2009. All reviewed the study protocol and agreed to participate. There was no compensation for study participants.
| Milestone | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
| Milestone | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
| Milestone | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| mm | Atorvastatin | Sugar Pill |
|---|---|---|
| Pre-post Change in Brachial Artery Reactivity | 3 ± 1.5 | 3 ± 1.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atorvastatin | — | 0/12 (0%) | 0/12 (0%) |
| Sugar Pill | — | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Age Continuous(years) | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| Mean | 35 ± 8.8 |
| Sex: Female, Male(Participants) | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| Female | 4 |
| Male | 8 |
| Region of Enrollment(participants) | Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin |
|---|---|
| United States | 12 |
The record gives a start of Aug 2008, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2013, 3 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atorvastatin
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