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The Effect of Lipitor on Aortic Stenosis

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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Valve Stenosis
Intervention Drug: atorvastatin (Lipitor)
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Period Title: Overall Study
Started 59
Completed 0
Not Completed 59
Reason Not Completed
Primary endpoint measure not obtainable             59
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
51
  86.4%
>=65 years
8
  13.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
14
  23.7%
Male
45
  76.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Aortic Stenosis
Hide Description aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population had aortic stenosis, however the primary endpoint of Aortic Valve Area was not obtainable due to poor reproducibility. As a result, the study was terminated.
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description:

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls
Hide Description 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.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description:

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls
Hide Description 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.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description:

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group
Hide Description 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.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description:

Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.
Hide Description 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.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description:

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AORTIC STENOSIS PATIENTS
Hide Arm/Group Description

Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily

All-Cause Mortality
AORTIC STENOSIS PATIENTS
Affected / at Risk (%)
Total   0/59 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AORTIC STENOSIS PATIENTS
Affected / at Risk (%)
Total   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AORTIC STENOSIS PATIENTS
Affected / at Risk (%)
Total   0/59 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Brian Griffin MD
Organization: Cleveland Clinic
Phone: 216-444-6812
Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00590135     History of Changes
Other Study ID Numbers: IRB 3516
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: April 18, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017