Trial Outcomes & Findings for The Effect of Lipitor on Aortic Stenosis (NCT NCT00590135)

NCT ID: NCT00590135

Last Updated: 2017-07-26

Results Overview

aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 59 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-07-26

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	59
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	59

Reasons for withdrawal

Measure	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
Overall Study Primary endpoint measure not obtainable	59

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	AORTIC STENOSIS PATIENTS n=59 Participants 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
Age, Categorical <=18 years	0 Participants n=59 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=59 Participants
Age, Categorical >=65 years	8 Participants n=59 Participants
Sex: Female, Male Female	14 Participants n=59 Participants
Sex: Female, Male Male	45 Participants n=59 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 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.

aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

AORTIC STENOSIS PATIENTS

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

Brian Griffin MD

Cleveland Clinic

Phone: 216-444-6812

Email: Griffib@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place