The Effect of Lipitor on Aortic Stenosis
|ClinicalTrials.gov Identifier: NCT00590135|
Recruitment Status : Terminated (Poor Reducibility - primary endpoint measure not obtainable)
First Posted : January 10, 2008
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Drug: atorvastatin (Lipitor)||Phase 4|
This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS cohorts will be used, employing the accepted rate of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for comparison, we will prospectively study a registry of AS patients who meet our entry criteria but are either currently already being treated with or refuse to take an HMG-CoA reductase inhibitor (referred to as the "standard care" group).
All patient visits, laboratory studies, and echocardiograms will be performed at the Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT measurement which may be done at the patient's local doctor's office and the results faxed to Imaging Research. The 12-week follow-up assessment may be completed over the phone to establish any change in patient status since baseline, study medication compliance, concomitant medication use and to ascertain whether or not the appropriate laboratory test was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis|
|Actual Study Start Date :||August 2000|
|Actual Primary Completion Date :||April 26, 2010|
|Actual Study Completion Date :||April 26, 2010|
U.S. FDA Resources
Experimental: AORTIC STENOSIS PATIENTS
Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
Drug: atorvastatin (Lipitor)
atorvastatin 40 mg by mouth once daily
Other Name: Lipitor
- Aortic Stenosis [ Time Frame: 2 years ]aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility
- Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls [ Time Frame: 2 years ]Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.
- Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls [ Time Frame: 2 years ]Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.
- Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group [ Time Frame: 2 years ]Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.
- Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group. [ Time Frame: 2 years ]Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590135
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Brian P Griffin, M.D.||The Cleveland Clinic|