Effect of Sublingual (under the tongue) Rosuvastatin/Crestor (cholesterol/statin medication) in reducing the side effects experienced in subjects with high cholesterol & a history of cardiovascular disease (heart attack, coronary artery disease) with a known statin intolerance.

Phase 2

Recruiting

• Conditions: coronary artery disease; Hyperlipidaemia; Diabetes; peripheral vascular disease; Cardiovascular - Coronary heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616001544460
• Lead Sponsor: Dr Gregory Szto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Has suffered side effects attributable to the statin including myalgia, abnormal liver function tests, and/or memory problems.
Has stopped taking statins more than 1 month prior to enrolment
Has existing total cholesterol of > 5.5 mmol/L
Has a history of cardiovascular ischaemic heart disease and is not yet at target levels TC< 4.0mmol/L

Exclusion Criteria

1.Has uncontrolled diabetes, defined by a HbA1c > 9% as measured at visit 1
2.Has alanine aminotransferase (ALT) > 1.5 times ULN as measured at visit 1
3.Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at visit 1
4.Has creatine kinase (CK) > 1.5 times ULN as measured at visit 1
5.Has triglycerides (TG) > 4.5 mmol/L as measured at visit 1
6.Has evidence of renal impairment with a serum creatinine of > 200 µmol/L as measured at visit 1
7.Has known drug or alcohol dependency within 6 months of visit 1
8.A woman receiving hormonal therapy, including hormone replacement, any oestrogen agonist/antagonist, or oral contraceptives
9.A woman of childbearing potential not using a an acceptable method of birth control (e.g. hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide)
10.Woman who is pregnant or breast feeding
11.Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Myalgia/muscle aches symptoms<br>[Myalgia will be evaluated by subjects reporting adverse events at day 7 post drug administration. A myalgia score using analogue tool will occur at day 21 & 42 in 1st arm post administration and day 84 & 105 post administration in 2nd arm.<br>Elevated muscle enzymes (CK) will be measured at days 7, 21 &42 post drug administration in 1st arm and day 84 & 105 post drug administration in 2nd arm.<br>As we are blinded, 1st arm may be rosuvastatin or placebo + 2nd arm may be rosuvastatin or placebo.<br>];change in total blood cholesterol[assessed by fasting blood test at 7, 21 and, 42 days post sublingual drug administration in 1st arm and days 84 & 105 post sublingual drug administration in 2nd arm.<br>As we are blinded, 1st arm may be rosuvastatin or placebo + 2nd arm may be rosuvastatin or placebo.]

Secondary Outcome Measures

Name	Time	Method
stable memory [assessed using Montreal cognitive assessment tool at day 42 post sublingual drug administration in 1st arm and day 105 post sublingual drug administration in 2nd arm <br>As we are blinded, 1st arm may be rosuvastatin or placebo + 2nd arm may be rosuvastatin or placebo.]