REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)
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ClinicalTrials.gov Identifier: NCT01252953 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 3, 2010
Last Update Posted
: March 21, 2017
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 24, 2010 | ||||||
First Posted Date ICMJE | December 3, 2010 | ||||||
Last Update Posted Date | March 21, 2017 | ||||||
Study Start Date ICMJE | June 2011 | ||||||
Actual Primary Completion Date | January 31, 2017 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Major coronary events (defined as coronary death, myocardial infarction or coronary revascularization procedure) [ Time Frame: Median follow-up of 4 years ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01252953 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
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? Following the main on-treatment part of the study, there will be a further period of at least 2 years during which participants will be followed-up by telephone, off treatment. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Atherosclerotic Cardiovascular Disease | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
30624 | ||||||
Original Estimated Enrollment ICMJE |
30000 | ||||||
Estimated Study Completion Date | April 2019 | ||||||
Actual Primary Completion Date | January 31, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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:
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Sex/Gender |
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Ages | 50 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01252953 | ||||||
Other Study ID Numbers ICMJE | CTSUREVEAL1 48678192 ( Registry Identifier: ISRCTN ) 2010-023467-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | University of Oxford | ||||||
Study Sponsor ICMJE | University of Oxford | ||||||
Collaborators ICMJE | Merck Sharp & Dohme Corp. | ||||||
Investigators ICMJE |
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PRS Account | University of Oxford | ||||||
Verification Date | March 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |