Atherosclerotic Cardiovascular DiseasePhase 3REVEALNCT01252953
REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification
A Phase 3 study testing Anacetrapib in people with Atherosclerotic Cardiovascular Disease, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Anacetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30,449 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to 31 Jan 2037
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- Previous significant adverse reaction to a statin or anacetrapib;
- Current treatment with any of the following lipid-lowering treatments:
- 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:
- any potent CYP3A4 inhibitor, such as:
- macrolide antibiotics (erythromycin, clarithromycin, telithromycin);
- systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole);
- protease inhibitors (e.g. atazanavir);
- nefazodone
- ciclosporin
- daptomycin
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CTSU, University of Oxford
Oxford, Oxfordshire, OX3 7LF
About this study
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
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.
Read the 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 was a further period of at least 2 years during which participants were followed-up by telephone, off treatment.
All participants stopped study treatment prior to February 2017 (results for the main-trial have been reported) and direct participant follow-up was completed in April 2019.
In the UK we will continue to collect information on health outcomes via central data registries and NHS sources for many years.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Anacetrapib, Placebo anacetrapib
- Keywords
- vascular disease, lipids, cholesteryl ester transfer protein (CETP) inhibition, anacetrapib
- Medical subject headings
- Atherosclerosis, Vascular Diseases, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnacetrapibDrug
tablet, 100mg daily
Placebo anacetrapibDrug
tablet, 1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Anacetrapib | Experimental | Not described Receives: Drug: Anacetrapib |
| Placebo anacetrapib | Placebo comparator | Not described Receives: Drug: Placebo anacetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Coronary Event
Primary assessment involves 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.
Data reported is for the first major coronary event.
Measured: Randomized treatment phase during median follow-up period of 4.1years
Secondary outcomes (3)
Number of Participants With Major Atherosclerotic Event
Major atherosclerotic events (defined as coronary death, myocardial infarction or presumed ischaemic stroke; the key secondary outcome).
Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period.
Measured: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Presumed Ischaemic Stroke
Presumed ischaemic stroke (i.e. not known to be haemorrhagic).
Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period.
Measured: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Major Vascular Event
Major vascular events (defined as coronary death, myocardial infarction, coronary revascularization or presumed ischaemic stroke).
Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period
Measured: Randomized treatment phase during median follow-up period of 4.1years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJun 2011
- Primary completion31 Jan 2017
- Study completion31 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30,449 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Martin Landray, Principal investigator, University of OxfordLouise Bowman, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252953
- Sponsor's protocol ID
- CTSUREVEAL1
- Other IDs
- 48678192, 2010-023467-18
- Acronym
- REVEAL
- Status last verified
- Jun 2024
- First submitted
- 24 Nov 2010
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Proposals for substudies must be approved by the Steering Committee. Procedures for accessing the data for this study are available on: https://www.ndph.ox.ac.uk/data-access.
Publications
REVEAL Collaborative Group; Bowman L, Chen F, Sammons E, Hopewell JC, Wallendszus K, Stevens W, Valdes- Marquez E, Wiviott S, Cannon CP, Braunwald E, Collins R, Landray MJ. Randomized Evaluation of the Effects of Anacetrapib through Lipid-modification (REVEAL)-A large-scale, randomized, placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease: Trial design, recruitment, and baseline characteristics. Am Heart J. 2017 May;187:182-190. doi: 10.1016/j.ahj.2017.02.021. Epub 2017 Feb 21.
PubMed 28454801HPS3/TIMI55-REVEAL Collaborative Group; Bowman L, Hopewell JC, Chen F, Wallendszus K, Stevens W, Collins R, Wiviott SD, Cannon CP, Braunwald E, Sammons E, Landray MJ. Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease. N Engl J Med. 2017 Sep 28;377(13):1217-1227. doi: 10.1056/NEJMoa1706444. Epub 2017 Aug 28.
PubMed 28847206Hopewell JC, Ibrahim M, Hill M, Shaw PM, Braunwald E, Blaustein RO, Bowman L, Landray MJ, Sabatine MS, Collins R; HPS3/TIMI55-REVEAL Collaborative Group. Impact of ADCY9 Genotype on Response to Anacetrapib. Circulation. 2019 Sep 10;140(11):891-898. doi: 10.1161/CIRCULATIONAHA.119.041546. Epub 2019 Jul 23.
PubMed 31331193HPS3/TIMI55-REVEAL Collaborative Group; Writing Committee; Sammons E, Hopewell JC, Chen F, Stevens W, Wallendszus K, Valdes-Marquez E, Dayanandan R, Knott C, Murphy K, Wincott E, Baxter A, Goodenough R, Lay M, Hill M, Macdonnell S, Fabbri G, Lucci D, Fajardo-Moser M, Brenner S, Hao D, Zhang H, Liu J, Wuhan B, Mosegaard S, Herrington W, Wanner C, Angermann C, Ertl G, Maggioni A, Barter P, Mihaylova B, Mitchel Y, Blaustein R, Goto S, Tobert J, DeLucca P, Chen Y, Chen Z, Gray A, Haynes R, Armitage J, Baigent C, Wiviott S, Cannon C, Braunwald E, Collins R, Bowman L, Landray M; REVEAL Collaborative Group. Long-term safety and efficacy of anacetrapib in patients with atherosclerotic vascular disease. Eur Heart J. 2022 Apr 6;43(14):1416-1424. doi: 10.1093/eurheartj/ehab863.
PubMed 34910136Lui JNM, Williams C, Keng MJ, Hopewell JC, Sammons E, Chen F, Gray A, Bowman L, Landray SMJ, Mihaylova B; REVEAL Collaborative Group. Impact of New Cardiovascular Events on Quality of Life and Hospital Costs in People With Cardiovascular Disease in the United Kingdom and United States. J Am Heart Assoc. 2023 Oct 3;12(19):e030766. doi: 10.1161/JAHA.123.030766. Epub 2023 Sep 26.
PubMed 37750555Castonguay M, Anderson MA, Thompson P, Seymour JF. Venetoclax retreatment in chronic lymphocytic leukemia is biologically rational and clinically effective. Blood Adv. 2026 May 26;10(10):3357-3366. doi: 10.1182/bloodadvances.2026019871.
PubMed 41843779Landmesser U, von Eckardstein A, Kastelein J, Deanfield J, Luscher TF. Increasing high-density lipoprotein cholesterol by cholesteryl ester transfer protein-inhibition: a rocky road and lessons learned? The early demise of the dal-HEART programme. Eur Heart J. 2012 Jul;33(14):1712-5. doi: 10.1093/eurheartj/ehs182. Epub 2012 Jun 13. No abstract available.
PubMed 22696435Krauss RM, Wojnooski K, Orr J, Geaney JC, Pinto CA, Liu Y, Wagner JA, Luk JM, Johnson-Levonas AO, Anderson MS, Dansky HM. Changes in lipoprotein subfraction concentration and composition in healthy individuals treated with the CETP inhibitor anacetrapib. J Lipid Res. 2012 Mar;53(3):540-547. doi: 10.1194/jlr.M018010. Epub 2011 Dec 17.
PubMed 22180633
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01252953
- Acronym / sponsor ID
- REVEAL / CTSUREVEAL1
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- vascular disease, lipids, cholesteryl ester transfer protein (CETP) inhibition, anacetrapib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,449 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2011
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2037 (estimated)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 4 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 was a further period of at least 2 years during which participants were followed-up by telephone, off treatment.
All participants stopped study treatment prior to February 2017 (results for the main-trial have been reported) and direct participant follow-up was completed in April 2019.
In the UK we will continue to collect information on health outcomes via central data registries and NHS sources for many years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anacetrapib | Experimental | Drug: Anacetrapib |
| Placebo anacetrapib | Placebo comparator | Drug: Placebo anacetrapib |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (29 listed)
- None of the following must be satisfied:
- Note: Individuals who are taking such drugs temporarily may be re-screened when they discontinue them, if considered appropriate;
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anacetrapibtablet, 100mg daily | Drug | Anacetrapib |
| Placebo anacetrapibtablet, 1 tablet daily | Drug | Placebo anacetrapib |
Primary outcome
Number of Participants With Major Coronary Event
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Primary assessment involves 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. Data reported is for the first major coronary event.
3 secondary outcomes
Number of Participants With Major Atherosclerotic Event
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Presumed Ischaemic Stroke
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Number of Participants With Major Vascular Event
Time frame: Randomized treatment phase during median follow-up period of 4.1years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28454801REVEAL Collaborative Group; Bowman L, Chen F, Sammons E, Hopewell JC, Wallendszus K, Stevens W, Valdes- Marquez E, Wiviott S, Cannon CP, Braunwald E, Collins R, Landray MJ. Randomized Evaluation of the Effects of Anacetrapib through Lipid-modification (REVEAL)-A large-scale, randomized, placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease: Trial design, recruitment, and baseline characteristics. Am Heart J. 2017 May;187:182-190. doi: 10.1016/j.ahj.2017.02.021. Epub 2017 Feb 21.
- Results publication: PubMed 28847206HPS3/TIMI55-REVEAL Collaborative Group; Bowman L, Hopewell JC, Chen F, Wallendszus K, Stevens W, Collins R, Wiviott SD, Cannon CP, Braunwald E, Sammons E, Landray MJ. Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease. N Engl J Med. 2017 Sep 28;377(13):1217-1227. doi: 10.1056/NEJMoa1706444. Epub 2017 Aug 28.
- Results publication: PubMed 31331193Hopewell JC, Ibrahim M, Hill M, Shaw PM, Braunwald E, Blaustein RO, Bowman L, Landray MJ, Sabatine MS, Collins R; HPS3/TIMI55-REVEAL Collaborative Group. Impact of ADCY9 Genotype on Response to Anacetrapib. Circulation. 2019 Sep 10;140(11):891-898. doi: 10.1161/CIRCULATIONAHA.119.041546. Epub 2019 Jul 23.
- Results publication: PubMed 34910136HPS3/TIMI55-REVEAL Collaborative Group; Writing Committee; Sammons E, Hopewell JC, Chen F, Stevens W, Wallendszus K, Valdes-Marquez E, Dayanandan R, Knott C, Murphy K, Wincott E, Baxter A, Goodenough R, Lay M, Hill M, Macdonnell S, Fabbri G, Lucci D, Fajardo-Moser M, Brenner S, Hao D, Zhang H, Liu J, Wuhan B, Mosegaard S, Herrington W, Wanner C, Angermann C, Ertl G, Maggioni A, Barter P, Mihaylova B, Mitchel Y, Blaustein R, Goto S, Tobert J, DeLucca P, Chen Y, Chen Z, Gray A, Haynes R, Armitage J, Baigent C, Wiviott S, Cannon C, Braunwald E, Collins R, Bowman L, Landray M; REVEAL Collaborative Group. Long-term safety and efficacy of anacetrapib in patients with atherosclerotic vascular disease. Eur Heart J. 2022 Apr 6;43(14):1416-1424. doi: 10.1093/eurheartj/ehab863.
- Results publication: PubMed 37750555Lui JNM, Williams C, Keng MJ, Hopewell JC, Sammons E, Chen F, Gray A, Bowman L, Landray SMJ, Mihaylova B; REVEAL Collaborative Group. Impact of New Cardiovascular Events on Quality of Life and Hospital Costs in People With Cardiovascular Disease in the United Kingdom and United States. J Am Heart Assoc. 2023 Oct 3;12(19):e030766. doi: 10.1161/JAHA.123.030766. Epub 2023 Sep 26.
- Derived from this study: PubMed 41843779Castonguay M, Anderson MA, Thompson P, Seymour JF. Venetoclax retreatment in chronic lymphocytic leukemia is biologically rational and clinically effective. Blood Adv. 2026 May 26;10(10):3357-3366. doi: 10.1182/bloodadvances.2026019871.
- Derived from this study: PubMed 22696435Landmesser U, von Eckardstein A, Kastelein J, Deanfield J, Luscher TF. Increasing high-density lipoprotein cholesterol by cholesteryl ester transfer protein-inhibition: a rocky road and lessons learned? The early demise of the dal-HEART programme. Eur Heart J. 2012 Jul;33(14):1712-5. doi: 10.1093/eurheartj/ehs182. Epub 2012 Jun 13. No abstract available.
- Derived from this study: PubMed 22180633Krauss RM, Wojnooski K, Orr J, Geaney JC, Pinto CA, Liu Y, Wagner JA, Luk JM, Johnson-Levonas AO, Anderson MS, Dansky HM. Changes in lipoprotein subfraction concentration and composition in healthy individuals treated with the CETP inhibitor anacetrapib. J Lipid Res. 2012 Mar;53(3):540-547. doi: 10.1194/jlr.M018010. Epub 2011 Dec 17.
- REVEAL trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Proposals for substudies must be approved by the Steering Committee. Procedures for accessing the data for this study are available on: https://www.ndph.ox.ac.uk/data-access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Landray principal investigator
University of Oxford
Louise Bowman principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anacetrapib in people with Atherosclerotic Cardiovascular Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Major Coronary Event (time frame: Randomized treatment phase during median follow-up period of 4.1years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252953, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.