Active not recruitingPHASE3INTERVENTIONAL

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

The REVEAL study investigated if a medication called anacetrapib could reduce the risk of serious heart and circulatory problems in people who already had these conditions. Participants, all of whom were over 50 and already taking statins for their cholesterol, received either anacetrapib or a dummy pill. Researchers wanted to see if anacetrapib lowered the chances of events like heart attacks or needing procedures to unblock arteries. The main part of the study involved taking the medication daily, followed by several years of health monitoring. The trial has now ended, with participants having stopped taking the study drug by early 2017. Their health information will continue to be collected in the UK to understand long-term effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Oxford

Enrolment target

30,449

Start

01 Jun 2011

Estimated completion

31 Jan 2037

Atherosclerotic Cardiovascular Disease

What is this study about?

The REVEAL trial was a large research study designed to understand if a specific medicine called anacetrapib could make a difference for people living with heart and circulatory diseases. These conditions can lead to serious health issues like heart attacks or the need for operations to improve blood flow to the heart. The main goal was to see if adding anacetrapib to a patient's existing statin treatment (which helps lower 'bad' cholesterol) could lower their risk of having these serious heart events.

Participants in the study were chosen because they already had a history of conditions like heart attacks, strokes, or circulation problems in their legs. They were all taking statins, which are common medications used to manage cholesterol. Half of the participants received the active drug, anacetrapib, while the other half received a 'dummy' pill (a placebo). This allows researchers to compare the effects of the active drug against no active treatment.

After the period of taking the study medication, all participants were followed up for several years, even after they stopped taking the experimental drug. In the UK, their health information will continue to be collected for many more years through health records. This long-term monitoring helps scientists understand the full impact of treatments over time. The main part of the trial has been completed, and the results have been published.

Key takeaways

The REVEAL trial investigated anacetrapib for people with heart and circulatory diseases.
It aimed to reduce serious heart events like heart attacks.
Participants were over 50, with existing heart problems, and already on statins.
The study compared anacetrapib to a dummy pill (placebo).
The main part of the study has finished, and results are available.
Long-term health monitoring will continue through health records in the UK.

Who may be eligible?

To be considered for the REVEAL study, people generally needed to be at least 50 years old. They also had to have a history of specific heart or circulatory problems. This could include having had a heart attack, a stroke, circulation issues in their legs, or diabetes alongside other signs of heart disease like angina or previous heart procedures.

However, there were certain reasons why someone couldn't join. For instance, if they had suffered a recent heart attack or stroke (within the last month), or if they were due to have a heart procedure within six months, they wouldn't be able to participate right away. People with severe kidney or liver problems, certain muscle diseases, or known allergies to statins or the study drug were also excluded.

Finally, if someone was already taking certain other types of strong cholesterol-lowering medications or medicines for certain conditions, they usually couldn't take part. This ensures that the study only tests the effects of anacetrapib clearly.

Quick self-check

Are you 50 years old or older?
Have you had a heart attack, stroke, or circulation problems in your legs?
Are you currently taking statins for your cholesterol?
Do you *not* have severe kidney or liver disease?
Have you *not* had a recent heart attack or stroke (within the last month)?
Are you *not* due for a heart procedure in the next six months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you had joined the REVEAL trial, you would have taken the study medication (either anacetrapib or a dummy pill) daily for a certain period. During this time, you would have had regular visits to the study clinic for checks and to ensure your health was stable. Once you stopped taking the study medication, which happened for everyone by early 2017, you would have still been part of the study for follow-up. This follow-up mainly involved telephone calls to check on your health status, and this direct contact finished in April 2019. In the UK, information about your health outcomes will continue to be gathered from your existing NHS records and other health registries for many years to come. The total duration from starting the treatment phase to the very long-term health record follow-up could span over a decade.

Potential risks and benefits

Participating in research studies like REVEAL can offer the potential benefit of contributing to medical knowledge that could help future patients. While there isn't a direct personal benefit guaranteed, you would have received close medical attention during the active treatment phase. Potential risks could have included side effects from the study drug, although these would have been carefully monitored. There's also the chance the study drug might not have been effective for you. Participants always had the right to withdraw from the study at any time, for any reason, without it affecting their usual medical care.

Locations (1)

CTSU, University of Oxford
Oxford, United Kingdom

Common questions

What was the main purpose of the REVEAL trial?

The main purpose was to see if a drug called anacetrapib could lower the risk of heart attacks and other serious heart problems in people already at risk.

Who could take part in this study?

People aged 50 or older who had a history of heart attacks, strokes, or other circulation problems, and were already taking statins, could take part.

Has the study finished?

Yes, the main treatment part of the study finished, and direct follow-up of participants ended in April 2019. Long-term health information will still be collected in the UK.

What was anacetrapib supposed to do?

Anacetrapib was being tested to see if it could improve cholesterol levels in a way that would help prevent heart events, especially when added to statin treatment.

What happens with my health information if I was in the study?

In the UK, your health information will continue to be collected from NHS records for many years, even after the direct study finished, to track long-term effects.