The Effect of Lipitor on Aortic Stenosis

NCT00590135

Last updated date
Study Location
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aortic Valve Stenosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve

- Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.

- Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Left ventricular ejection fraction <50%


- Valvular area of 0.9 cm2 and a mean gradient >30 mmHg


- Rheumatic heart disease


- >Moderate (2+) aortic insufficiency


- Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other
HMG-CoA Reductase Inhibitors (statins)


- End-stage renal disease (ESRD)


- History of thoracic radiation


- Unable or unwilling to sign informed consent


- Unable to unwilling to return for follow-up


- Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or
hematological disorders, vasculitis, or any other situation or medical condition that,
in the investigator's opinion, would make survival for the duration of the study
unlikely, or would otherwise interfere with optimal participation in the study or
produce a significant risk to the patient


- Severe pulmonary hypertension (>55 mmHg)

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Aortic Valve StenosisThe Effect of Lipitor on Aortic Stenosis
NCT00590135
  1. Cleveland, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect of Lipitor on Aortic Stenosis
Official Title  ICMJE The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis
Brief Summary The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE Drug: atorvastatin (Lipitor)
atorvastatin 40 mg by mouth once daily
Other Name: Lipitor
Study Arms  ICMJE Experimental: AORTIC STENOSIS PATIENTS
Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
Intervention: Drug: atorvastatin (Lipitor)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 9, 2008)
59
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 26, 2010
Actual Primary Completion Date April 26, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
  • Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
  • Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.

Exclusion Criteria:

  • Left ventricular ejection fraction <50%
  • Valvular area of 0.9 cm2 and a mean gradient >30 mmHg
  • Rheumatic heart disease
  • >Moderate (2+) aortic insufficiency
  • Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins)
  • End-stage renal disease (ESRD)
  • History of thoracic radiation
  • Unable or unwilling to sign informed consent
  • Unable to unwilling to return for follow-up
  • Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
  • Severe pulmonary hypertension (>55 mmHg)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00590135
Other Study ID Numbers  ICMJE IRB 3516
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Brian P Griffin, M.D.The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP