Study to assess the long-term effects of treating cholesterol with anacetrapib

Phase 1

• Conditions: Atherosclerotic cardiovascular disease; MedDRA version: 20.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-023467-18-DK
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-24
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30449

Inclusion Criteria

Patients must be aged at least 50 at the time of initial invitation, and at least one of the following inclusion criteria must
be satisfied:
• History of MI; or
• Cerebrovascular atherosclerotic disease (i.e. history of presumed ischaemic stroke or carotid revascularization); or
• Peripheral arterial disease (i.e. history of noncoronary
revascularization, including aortic aneurysm repair or graft); or
• Diabetes mellitus with other evidence of symptomatic coronary heart disease (i.e. treatment or hospitalisation for
angina, or a history of coronary revascularization or acute coronary syndrome).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15000

Exclusion Criteria

None of the following must be satisfied:
• Acute MI, acute coronary syndrome or stroke within 4 weeks prior to Screening Visit or during Runin (but such individuals may be entered later, if appropriate);
• Planned coronary revascularization procedure within the next 6 months (such individuals may be entered later, if appropriate);
• Definite history of chronic liver disease, or abnormal liver function (i.e. ALT >2x ULN). Note: Individuals with a history of acute hepatitis are eligible provided this ALT limit is not exceeded;
• Severe renal insufficiency (i.e. creatinine >200 µmol/L, dialysis or functioning renal transplant);
• Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or CK >3x ULN;
• Previous significant adverse reaction to a statin or anacetrapib;
• Current treatment with any of the following lipid-lowering treatments:
(i) a regimen considered to produce substantially greater LDL cholesterol reduction than atorvastatin 80 mg daily;
(ii) fibric acid derivative (fibrate, including gemfibrozil); or
(iii) niacin (nicotinic acid) at doses above 100mg daily;
• Concurrent treatment with a medication that is contraindicated with anacetrapib or atorvastatin:
(i) any potent CYP3A4 inhibitor, such as:
(a) macrolide antibiotics (erythromycin, clarithromycin, telithromycin);
(b) daptomycin
(c) systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole);
(d) protease inhibitors (e.g. atazanavir);
(e) nefazodone
(ii) ciclosporin
(iii) systemic use of fusidic acid
Note: Individuals who are taking such drugs temporarily may be rescreened when they discontinue them, if considered appropriate;
• Known to be poorly compliant with clinic visits or prescribed medication;
• Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 5 years, other than nonmelanoma skin cancer; or recent history of alcohol or substance misuse);
• Women of childbearing potential (unless using adequate contraception);
• Current participation in a clinical trial with an unlicensed drug or device.

Individuals will also be excluded at the Screening visit if it is considered unlikely that they will achieve total cholesterol <3.5 mmol/L on the highest atorvastatin dose (80 mg daily).

In addition, individuals will be excluded at the Randomization visit if any of the following are true:
• Total cholesterol (on desktop analyser) above 4 mmol/L
• Noncompliant with run-in treatment (<90% scheduled run-in medication taken)
• Individual is no longer willing to be randomized into the 45 year trial
• The individual’s doctor is of the view that their patient should not be randomized.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified