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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AORTIC STENOSIS PATIENTS

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


Participant Flow:   Overall Study
    AORTIC STENOSIS PATIENTS
STARTED   59 
COMPLETED   0 
NOT COMPLETED   59 
Primary endpoint measure not obtainable                59 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AORTIC STENOSIS PATIENTS

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


Baseline Measures
   AORTIC STENOSIS PATIENTS 
Overall Participants Analyzed 
[Units: Participants]
 59 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   59 
<=18 years      0   0.0% 
Between 18 and 65 years      51  86.4% 
>=65 years      8  13.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   59 
Female      14  23.7% 
Male      45  76.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Aortic Stenosis   [ Time Frame: 2 years ]

2.  Secondary:   Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls   [ Time Frame: 2 years ]

3.  Secondary:   Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls   [ Time Frame: 2 years ]

4.  Secondary:   Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group   [ Time Frame: 2 years ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Griffib@ccf.org


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