Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01663402) enrolled 9,462 people in each group — one group received a placebo (an inactive injection) and the other received a medicine called alirocumab, given every two weeks. The trial was measuring how often serious heart and blood vessel events — such as heart attacks, strokes, deaths from heart disease, or hospitalisation for unstable chest pain — occurred over the course of the study. Around 7,900 people in the placebo group and around 7,400 in the alirocumab group completed the study. The reported data shows that for the main outcome — the first serious heart or blood vessel event — 11.1% of participants in the placebo group and 9.5% of participants in the alirocumab group experienced such an event during the study. For the secondary outcomes, the reported data shows: any coronary heart disease event occurred in 14.3% (placebo) versus 12.7% (alirocumab); any major coronary heart disease event (heart disease death or heart attack) in 9.5% versus 8.4%; any cardiovascular event in 15.6% versus 13.7%; and the combined measure of death from any cause, non-fatal heart attack, or non-fatal stroke in 11.9% versus 10.3%. Death specifically from coronary heart disease was reported in 2.3% of the placebo group and 2.2% of the alirocumab group. These figures are the percentages of observed participants who experienced each event at least once during the trial period, as recorded and independently reviewed by a medical committee. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Heart Disease Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You were hospitalised in the last 52 weeks (about one year) for a serious heart condition called Acute Coronary Syndrome (ACS), which includes events like a heart attack or severe chest pain caused by blocked arteries.
Who may not be able to join:
- You are younger than 40 years old.
- Your hospitalisation for the heart condition happened more than 52 weeks (about one year) before the trial enrolment visit.
- Your blood cholesterol and fat levels are already well controlled through diet and medication, meaning certain specific cholesterol measurements (LDL-C, ApoB, and non-HDL-C) are all below set low levels at the same time (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
25 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.