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REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01252953
First received: November 24, 2010
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL) trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the risk of coronary death, myocardial infarction (MI) or coronary revascularization (collectively known as major coronary events) in patients with circulatory problems who have their Low-density Lipoprotein (LDL) cholesterol level treated with a statin.


Condition Intervention Phase
Atherosclerotic Cardiovascular Disease
Drug: anacetrapib
Drug: placebo anacetrapib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification. A Large-scale, Randomized Placebo-controlled Trial of the Clinical Effects of Anacetrapib Among People With Established Vascular Disease

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Major coronary events (defined as coronary death, myocardial infarction or coronary revascularization procedure) [ Time Frame: Median follow-up of 4 years ] [ Designated as safety issue: No ]
    Primary assessment will involve an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib versus placebo on major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period.


Enrollment: 30624
Study Start Date: June 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anacetrapib Drug: anacetrapib
tablet, 100mg daily
Placebo Comparator: placebo anacetrapib Drug: placebo anacetrapib
tablet, 1 tablet daily

Detailed Description:

Sub-study: Does anacetrapib as a CETP inhibitor lead to mobilization of stem cells and enhance myocardial function via neoangiogenesis and tissue regeneration?

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 non-coronary revascularization, including aortic aneurysm repair or graft); or
    • Diabetes mellitus with other evidence of symptomatic coronary heart disease (i.e. treatment or hospitalization for angina, or a history of coronary revascularization or acute coronary syndrome).

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 Run-in (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. alanine transaminase (ALT) >2x the upper limit of normal (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 [2.3 mg/dL], dialysis or functioning renal transplant);
    • Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (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 for individuals in non-Asian countries or 20 mg daily for those in North East Asia; or (ii) fibric acid derivative ("fibrate", including gemfibrozil); or (iii) niacin (nicotinic acid) at doses above 100 mg daily

    • Concurrent treatment with a medication that is contraindicated with anacetrapib or atorvastatin:

      (i) any potent CYP3A4 inhibitor, such as:

      1. macrolide antibiotics (erythromycin, clarithromycin, telithromycin);
      2. systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole);
      3. protease inhibitors (e.g. atazanavir);
      4. nefazodone

        (ii) ciclosporin

        (iii) daptomycin

        (iv) systemic use of fusidic acid

        Note: Individuals who are taking such drugs temporarily may be re-screened 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 non-melanoma skin cancer; or recent history of alcohol or substance misuse);
    • Women of child-bearing 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 (135 mg/dL) on the highest atorvastatin dose available in their region (atorvastatin 80 mg daily in non-Asian countries or 20 mg daily in North East Asia).

In addition, individuals will be excluded at the Randomization visit if any of the following are true:

  • Total cholesterol above 4 mmol/L [155 mg/dL]
  • Non-compliant with run-in treatment (<90% scheduled run-in medication taken)
  • Individual is no longer willing to be randomized into the 4-5 year trial
  • The individual's doctor is of the view that their patient should not be randomized.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252953

Locations
United Kingdom
CTSU, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7LF
Sponsors and Collaborators
University of Oxford
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Martin Landray University of Oxford
Principal Investigator: Louise Bowman University of Oxford
  More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01252953     History of Changes
Other Study ID Numbers: CTSUREVEAL1, 48678192, 2010-023467-18
Study First Received: November 24, 2010
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
China: Food and Drug Administration
Canada: Health Canada
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Denmark: Danish Health and Medicines Authority
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency

Keywords provided by University of Oxford:
vascular disease
lipids
cholesteryl ester transfer protein (CETP) inhibition
anacetrapib

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anacetrapib
Oxazolidinones
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2014