atural products to lower cholesterol

Phase 3

• Conditions: hyperlipidemia; Cardiovascular - Other cardiovascular diseases; cardiovascular disease; statin intolerance

• Registration Number: ACTRN12618000660280
• Lead Sponsor: Curtin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-24
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Patients who are intolerant to statins and not currently achieving lipid targets (fasting LDL-c >1.8 mmol/L and <7 mmol/L). Statin intolerance will be defined as an inability to tolerate 2 or more statins, one at a low dose, due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued. Low dose statin therapy is defined as an average daily dose of rosuvastatin 5mg, atorvastatin 10mg, simvastatin 10mg, lovastatin 20mg, pravastatin 40mg, fluvastatin 40mg or pitavastatin 2mg. Patients tolerating very low dose statin therapy (rosuvastatin <5mg, atorvastatin <10mg, simvastatin <10mg, lovastatin <20mg, pravastatin <40mg, fluvastatin <40mg or pitavastatin <2mg) are considered to be intolerant to that low dose statin.

Exclusion Criteria

- Participants with pre-existing coronary artery disease (calcium score >0, previous coronary event) who are currently taking Ezetimibe or other cholesterol-lowering medication
- No documented statin intolerance
- Abnormal biochemistry at screening suggestive of an additional underlying cause of statin intolerance
- Pregnant or lactating women
- Inability to provide informed written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides) as assessed via fasting blood sample following a 12 hour fast.[Baseline, 4 weeks and 8 weeks (primary timepoint) after intervention commencement.]

Secondary Outcome Measures

Name	Time	Method
Development of side effects as assessed by plasma creatinine kinase measures as an indication of myopathy.[Baseline, 4 weeks and 8 weeks after intervention commencement.];Perceived quality of life as assessed by the validated EQUAL quality of life questionnaire.[Baseline and 8 weeks after intervention commencement.]