New study tests powerful cholesterol drug right after heart attacks
NCT ID NCT04951856
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding evolocumab (Repatha) to standard care helps people who recently had a heart attack reach very low LDL cholesterol levels and avoid death or unplanned heart-related hospital stays. About 2,166 participants with STEMI or NSTEMI will be randomly assigned to evolocumab injections every two weeks or usual care. The trial is active but no longer recruiting, and results are expected to show if this approach is better than standard cholesterol management.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Evolocumab (Repatha), a cholesterol-lowering injection
- What this could lead to
- If it works, this could show that adding evolocumab right after a heart attack helps more people reach very low cholesterol goals and reduces the risk of death or heart-related hospital stays.
- What could go wrong
- This is a phase 4 trial, so the drug is already approved, but it may not prove a clear benefit over standard care. Side effects like injection-site reactions or muscle pain are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 2,166 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participant meeting all of the following criteria will be considered for enrolment into the trial: 1. Diagnosis of STEMI or NSTEMI STEMI defined as: * symptoms of acute MI of at least 30 min AND * within the previous 24 hours with new persistent ST-segment elevation ≥1 mm in ≥2 continuous ECG leads AND * an indication for primary PCI AND * \> 55 years reported by the patient NSTEMI defined as: * Age≥18 * a history of chest discomfort or ischemic symptoms of ≥10 minutes duration at rest ≤48 hours prior to entry into the trial with no evidence of persistent ST-segment elevation and with an elevated troponin (≥ the upper limit of normal according to local laboratory norms), AND * indication for a coronary angiogram within 72hrs AND * indication for PCI AND * at least one the following high-risk characteristics: Diabetes Peripheral Artery Disease Multivessel (≥ 2 or LM) disease on the coronary angiogram History of MI or stroke without sequels prior to randomization eGFR: 15 to 45 mL/min/1.73 m2 calculated with MDRD formula at randomization 2. Statin at maximal tolerated dose, as part of the standard of care at randomization, means Intent to treat with statin and the patient will receive his first dose as soon as possible after admission 3. Informed consent obtained in writing at enrolment into the trial Exclusion Criteria: Participant presenting with any of the following will not be included in the trial: 1. Fibrinolysis treatment 2. Planned CABG 3. Ongoing hemodynamic instability defined as any of the following: * Killip Class III or IV * Sustained and/or symptomatic hypotension (systolic blood pressure \< 80 mm Hg) * Known left ventricular ejection fraction \< 30% 4. Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis 5. Active malignancy 6. A comorbid condition with an estimated life expectancy of ≤ 12 months 7. Previously received or receiving evolocumab or any other therapy to inhibit PCSK9 8. Known sensitivity to any of the products or components to be administered during trial 9. Female subject is pregnant, had a positive pregnancy test at inclusion, breastfeeding, or planning to become pregnant or breastfeed during treatment and for an additional 17 weeks after the last dose of IMP 10. Currently receiving treatment in any other investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial. 11. Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
Paris, 75013, France
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