Trial Outcomes & Findings for Statins and Endothelial Function in Patients With Coarctation of the Aorta (NCT NCT00767572)

Last Updated: 2013-10-14

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2013-10-14

Participant Flow

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.

Patients were excluded if they did not have prior repair of aortic coarctation or could not participate in all 4 study visits.

Participant milestones

Participant milestones
Measure	Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
First Intervention (12 Weeks) STARTED	12
First Intervention (12 Weeks) COMPLETED	12
First Intervention (12 Weeks) NOT COMPLETED	0
Washout (4 Weeks) STARTED	12
Washout (4 Weeks) COMPLETED	12
Washout (4 Weeks) NOT COMPLETED	0
Second Intervention (12 Weeks) STARTED	12
Second Intervention (12 Weeks) COMPLETED	12
Second Intervention (12 Weeks) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Statins and Endothelial Function in Patients With Coarctation of the Aorta

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin n=12 Participants Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	35 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: 12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.

Outcome measures

Outcome measures
Measure	Atorvastatin n=12 Participants 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.	Sugar Pill n=12 Participants 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.
Pre-post Change in Brachial Artery Reactivity	3 mm Standard Deviation 1.5	3 mm Standard Deviation 1.5

Adverse Events

Atorvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Doreen DeFaria Yeh

UCSF

Phone: 617-643-7024

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place