Evolve-Mi

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

8 Jan 2024 → ongoing

Decision date (initial)

2024-04-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-509268-26-00

EudraCT number

2021-005272-19

ClinicalTrials.gov

NCT05284747

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the effectiveness of treatment with evolocumab plus routine lipid management compared with 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 (NSTEMI and STEMI).

Secondary objectives 3

1. To evaluate the effectiveness of treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting on percent reduction of low-density lipoprotein cholesterol (LDL-C) at 12 weeks and 52 weeks following initiation.
2. To evaluate the effectiveness of 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 cardiovascular death in subjects hospitalized for an acute myocardial infarction (NSTEMI and STEMI).
3. To evaluate the effect of treatment with evolocumab plus routine lipid management vs routine lipid management alone on the risk of: first myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death.

Conditions and MedDRA coding

Dyslipidemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures; OR, subject’s legally authorized representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
2. Age ≥ 18 years (eg, if no upper age limit).
3. Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease.

Exclusion criteria 12

1. Patients requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
2. Patients with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy).
3. History or evidence of clinically significant disease (eg, malignancy, respiratory, gastrointestinal, renal or psychiatric disease) or unstable disorder that, in the opinion of the investigator(s), Amgen physician or designee would pose a risk to the patient’s safety or interfere with the study assessments, procedures, completion, or result in a life expectancy of less than 1 year.
4. Previously received or receiving any therapy to inhibit PCSK9 in the following timeframe: • Evolocumab, alirocumab, or any other monoclonal antibody against PCSK9 within 3 months prior to screening. • Inclisiran within 6 months prior to screening.
5. Currently receiving treatment in another investigational (not approved for any use in the country the subject is to be randomized) device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
6. Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 15 weeks after the last dose of investigational product.
7. Female subjects who are breastfeeding or who plan to breastfeed while on study through 15 weeks after the last dose of investigational product.
8. Female subjects planning to become pregnant while on study through 15 weeks after the last dose of investigational product.
9. Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
10. Subject has known sensitivity to any of the products or components to be administered during dosing.
11. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death.

Secondary endpoints 9

1. Percent LDL-C change from baseline to 12 weeks and 52 week in a subset of approximately 300 selected subjects.
2. Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death.
3. Time to the first occurrence of the composite of myocardial infarction, ischemic stroke, revascularization procedure, and all-cause death.
4. Total myocardial infarctions
5. Total arterial revascularization procedures
6. Total ischemia-driven coronary revascularization procedures
7. Total ischemic strokes
8. Cardiovascular death
9. All-cause death

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Thiago Oliveira

Public contact point

Organisation

Amgen Inc.

Contact name

Thiago Oliveira

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications