Cholesterol-Lowering Medication for Heart Attack

(EVOLVE-MI Trial)

Not currently recruiting at 150 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Amgen

Disqualifiers: Sepsis, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding evolocumab (Repatha) to regular cholesterol-lowering treatments can better prevent heart-related problems after a heart attack. Evolocumab lowers cholesterol levels. The trial compares two groups: one receiving evolocumab plus routine care and another receiving only routine care. It seeks participants hospitalized due to a heart attack from clogged arteries. Participants should not have heart problems from other causes like infections or abnormal heart rhythms. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on adding evolocumab to your routine lipid management, so you might be able to continue your current meds, but it's best to confirm with the trial coordinators.

What is the safety track record for these treatments?

Research has shown that evolocumab is generally safe. In a large study involving over 27,000 people, researchers tracked the safety of evolocumab for more than two years. Participants reported some common side effects, mostly mild, such as colds and back pain. Serious side effects were rare. These findings suggest that evolocumab is well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about evolocumab for lowering cholesterol because it works differently from traditional treatments like statins. Unlike most cholesterol medications that reduce cholesterol production in the liver, evolocumab is a monoclonal antibody that targets and inhibits PCSK9, a protein that affects the liver's ability to remove LDL cholesterol from the blood. This unique mechanism allows for significant cholesterol reduction, especially for individuals who can't tolerate statins or need additional lowering beyond what statins can provide. Furthermore, evolocumab is administered via an injection every two weeks, offering a convenient option for those who struggle with daily oral medications.

What evidence suggests that evolocumab plus routine lipid management could be effective for heart attack patients?

In this trial, participants will receive either evolocumab plus routine lipid management or routine lipid management alone. Previous studies have shown that evolocumab significantly lowers the risk of major heart problems, such as heart attacks and strokes. One study found that adding evolocumab to regular cholesterol treatment reduced these risks by about 20% over a few years. This treatment effectively lowers "bad" cholesterol levels, helping to prevent heart-related issues. Another study demonstrated that evolocumab decreases the chance of dying from heart problems, as well as the risk of heart attacks and strokes. Research agrees that evolocumab effectively manages cholesterol and prevents serious heart issues. ^{1 6 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are hospitalized due to a heart attack (NSTEMI or STEMI) presumed to be caused by plaque buildup in the arteries. It's not open to those needing intensive support like pumps or drugs for blood pressure at screening, or if their heart damage isn't due to artery issues.

Inclusion Criteria

I was hospitalized for a heart attack caused by blocked arteries.

Exclusion Criteria

I have heart damage not caused by blocked arteries, like from an infection or uncontrolled high blood pressure.

I need machines or drugs to help my heart and blood pressure work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive open-label evolocumab every 2 weeks plus routine lipid management

52 weeks

Bi-weekly visits for evolocumab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Evolocumab
• Routine Lipid Management

Trial Overview The EVOLVE-MI study tests whether giving Evolocumab with standard cholesterol management right after a heart attack is better than just routine care alone. The goal is to see if this can reduce further heart attacks, strokes, surgeries on arteries, and deaths.

How Is the Trial Designed?

Group I: Evolocumab + Routine Lipid Management Experimental Treatment 2 Interventions

Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.

Group II: Routine Lipid Management Active Control 1 Intervention

Participants will receive routine lipid management per standard of care (SoC).

Evolocumab is already approved in United States, European Union for the following indications:

Approved in United States as Repatha for:

• To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease
• Familial hypercholesterolemia
• High-risk patients with LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL on maximally tolerated statin therapy ± ezetimibe

Approved in European Union as Repatha for:

• Primary hypercholesterolaemia and mixed dyslipidaemia
• Homozygous familial hypercholesterolaemia

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Colorado Prevention Center

Collaborator

Trials

13

Recruited

22,600+

Published Research Related to This Trial

Evolocumab (Repatha(®)) is an effective injectable treatment for patients with familial hypercholesterolemia or statin intolerance, helping to significantly lower LDL cholesterol levels when statins alone are insufficient.

The review highlights the safety and efficacy of evolocumab based on results from various clinical trials, indicating its potential role as a second-line therapy after maximally tolerated statin therapy and lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PCSK9 inhibitors and their role in high-risk patients in reducing LDL cholesterol levels: evolocumab. Dahagam, C., Goud, A., Abdelqader, A., et al.[2021]

Evolocumab is a monoclonal antibody that significantly reduces LDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, showing treatment differences of 54.8% to 76.3% compared to placebo and 36.9% to 47.2% compared to ezetimibe over 12-week trials.

It is effective even in patients who are statin-intolerant or have homozygous familial hypercholesterolemia, maintaining its efficacy over the long term and demonstrating good tolerability, making it a valuable treatment option for those who struggle to achieve LDL-C goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolocumab: A Review in Hyperlipidemia. Keating, GM.[2019]

Evolocumab (Repatha™) is an effective treatment for hypercholesterolaemia, approved in the EU and awaiting approval in the USA and Japan, that works by binding to PCSK9, enhancing the liver's ability to remove LDL-cholesterol from the blood.

The drug can be used alone or alongside statins and other lipid-lowering therapies, showing efficacy in both adults and adolescents with various forms of hypercholesterolaemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolocumab: First Global Approval. Markham, A.[2020]

Evolocumab (Repatha) is an FDA-approved PCSK9 inhibitor that can reduce LDL-cholesterol levels by approximately 60% in high-risk patients already on maximum statin therapy, showing similar efficacy and safety to another PCSK9 inhibitor, alirocumab (Praluent).

The long-term effects of evolocumab on cardiovascular outcomes and its overall safety profile are still not fully established, and both evolocumab and alirocumab are considered expensive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolocumab (Repatha)--a second PCSK9 inhibitor to lower LDL-Cholesterol. [2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38325990/

Long-Term Efficacy of Evolocumab in Patients With or ... Evolocumab reduced the rate of major adverse cardiovascular event in patients with and without MVD. The benefit tended to occur earlier and was larger in ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1615664

Evolocumab and Clinical Outcomes in Patients with ... Evolocumab significantly reduced the risk of the primary composite end point of cardiovascular death, myocardial infarction, stroke, ...

3. repathahcp.com repathahcp.com/efficacy

FOURIER Trial | Repatha® (evolocumab) Repatha + statin was proven to reduce the risk of composite CV events by 20% in a median of only 2.2 years, and the benefit improved over time in the study.

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2766279

Efficacy of Evolocumab on Cardiovascular Outcomes in ... Evolocumab significantly reduced the risk of the composite outcome of cardiovascular death, MI, stroke, unstable angina, or coronary revascularization by 19%.

5. amgen.com amgen.com/newsroom/press-releases/2017/03/landmark-outcomes-study-shows-that-repatha-evolocumab-decreases-ldlc-to-unprecedented-low-levels-and-reduces-risk-of-cardiovascular-events-with-no-new-safety-issues

Landmark Outcomes Study Shows That Repatha ... Repatha Significantly Reduces Risk of Hard Major Adverse Cardiovascular Events by 20 Percent. Risks of Heart Attack, Stroke and Coronary ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK611323/

Clinical Review - Evolocumab (Repatha) - NCBI Bookshelf - NIH study, the composite end point of cardiovascular death, MI, and stroke was met by 6.45% (n = 182) of patients taking evolocumab versus 8.58% (n = 248) of ...

7. repathahcp.com repathahcp.com/safety

Safety Profile | Repatha® (evolocumab) In the Repatha CV Outcomes Trial (FOURIER), safety was established in more than 27K PATIENTS over a median of 2.2 years of follow-up.

8. amgen.com amgen.com/newsroom/press-releases/2025/08/repatha-now-indicated-for-adults-at-increased-risk-for-major-adverse-cardiovascular-events-due-to-uncontrolled-ldl-c

REPATHA® NOW INDICATED FOR ADULTS AT ... Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more ...

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.061620

Long-Term Evolocumab in Patients With Established ... A reduction in cardiovascular death was not observed over a median of 2.2 years, although there was a nonstatistically significant lower risk of ...