Trial Outcomes & Findings for Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging (NCT NCT00770679)

Results Overview

Serum LDL, mg/dL (baseline LDL-follow-up LDL)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Change from baseline to follow-up, up to 5 weeks

Results posted on

2017-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	High-Dose Statin 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Overall Study STARTED	16
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	High-Dose Statin 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Overall Study Lost to Follow-up	3
Overall Study Follow-up LDL measurement not collected	3

Baseline Characteristics

Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-Dose Statin n=16 Participants 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Age, Customized >=40, <=90, years	16 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to follow-up, up to 5 weeks

Population: 3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up

Serum LDL, mg/dL (baseline LDL-follow-up LDL)

Outcome measures

Outcome measures
Measure	High-Dose Statin n=10 Participants 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Mean Change in Low Density Lipoprotein (LDL)	75.54 mg/dL Standard Deviation 12.98

PRIMARY outcome

Timeframe: chance from baseline to end of study, up to 5 weeks

Population: No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: chance from baseline to end of study, up to 5 weeks

Population: No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.

Outcome measures

Outcome data not reported

Adverse Events

High-Dose Statin

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

Harry Silber, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology

Johns Hopkins University School of Medicine

Phone: 4105505717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place