Conditions
Arteriosclerosis, Hypercholesterolaemia
Trial Purpose
This is a phase 3, randomised, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischaemic stroke, myocardial infarction (MI), acute limb ischaemia or major amputation, or urgent arterial revascularisation.
NATIONAL TRIAL REFERENCE NUMBER
NCT06008756
EU CT
2022-502781-24-00
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Trial
Trial Phase
Trial Phase 3
Length of study: The CORALreef Outcomes study lasts on average 4.5 years, up to 6 years.
Trial start and end dates
- Actual study start date 9 October 2023
- Estimated primary completion date 29 November 2029
- Estimated study completion date 29 November 2029
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about