Cholesterol-Lowering Medication for Heart Attack

(EVOLVE-MI Trial)

Recruiting at 138 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

6019 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction \[NSTEMI\] and ST-segment elevation myocardial infarction \[STEMI\]).

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 data supports the effectiveness of the drug Evolocumab (Repatha) for lowering cholesterol in heart attack patients?

Evolocumab (Repatha) is shown to significantly lower LDL cholesterol (the 'bad' cholesterol) levels by about 60% in patients who are already taking the highest dose of statins, which are common cholesterol-lowering drugs. This reduction in LDL cholesterol is important because high levels are linked to a higher risk of heart attacks. ^{1 2 3 4 5}

Is evolocumab (Repatha) safe for humans?

Evolocumab (Repatha) has been shown to be well tolerated in clinical trials for lowering cholesterol, with no major safety concerns reported. However, its long-term safety is still unknown. ^{1 2 3 4 5}

How is the drug Evolocumab (Repatha) unique in treating high cholesterol?

Evolocumab (Repatha) is unique because it is a monoclonal antibody that targets PCSK9, a protein that affects the liver's ability to remove LDL cholesterol from the blood. Unlike traditional statins, it is administered via injection every two weeks or once a month, making it a novel option for patients who cannot tolerate statins or need additional cholesterol-lowering beyond what statins can provide. ^{1 2 3 5 6}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Evolocumab: First Global Approval. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Evolocumab: A Review in Hyperlipidemia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Pharmaceutical Approval Update. [2020]

5. England pubmed.ncbi.nlm.nih.gov

PCSK9 inhibitors and their role in high-risk patients in reducing LDL cholesterol levels: evolocumab. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Eligibility for PCSK9 treatment in 734 Hypercholesterolemic patients referred to a regional cholesterol treatment center with LDL cholesterol ≥ 70 mg/dl despite maximal tolerated cholesterol lowering therapy. [2021]