AMUNDSEN - Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world - The AMUNDSEN-real trial-

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

29 Sep 2021 → ongoing

Decision date (initial)

2024-11-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AMGEN

External identifiers

EU CT number

2024-518195-31-00

EudraCT number

2021-000573-80

ClinicalTrials.gov

NCT04951856

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary clinical objective is to demonstrate the superiority of evolocumab versus standard of care on the composite endpoint of death or any unplanned hospitalization for a CV reason at 12 months.

Secondary objectives 6

1. Evaluate the superiority of evolocumab vs. standard of care on LDL-C control (40mg/dL) at 12 months follow-up
2. Evaluate the superiority of evolocumab vs. standard of care on quadruple endpoint at 12 months follow-up
3. Evaluate the superiority of evolocumab vs. standard of care on triple endpoint at 12 months follow-up
4. Evaluate the superiority of evolocumab vs. standard of care on double endpoint at 12 months follow-up
5. Evaluate the superiority of evolocumab vs. standard of care on all-cause death at 12 months follow-up
6. Evaluate the superiority of evolocumab vs. standard of care on CV death at 12 months follow-up

Conditions and MedDRA coding

acute myocardial infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female
2. Diagnosis of 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
3. or, with a non-ST-segment elevation myocardial infarction (NSTEMI) defined by : Angiography performed within 72 hours, AND Indication for percutaneous coronary intervention, AND Presenting at least one of the following risk factors: Diabetes, Peripheral arterial disease, Multitruncular disease (≥ 2 or common trunk) confirmed by angiography, Previous myocardial infarction or stroke without sequelae prior to randomisation, eGFR creatinine clearance: 15 to 45 mL/min/1.73 m² calculated according to the MDRD formula at randomisation.
4. Statin at the maximum tolerated dose as part of standard management, i.e. intention to treat with a statin as soon as possible at randomisation
5. Inform consent obtained in writing at enrolment in the trial

Exclusion criteria 11

1. Fibrinolytic treatment
2. Scheduled bypass
3. Current haemodynamic instability defined by either : Killip III or IV, Symptomatic and/or sustained hypotension (systolic pressure <80 mmHg), Known left ventricular ejection fraction < 30%.
4. Evidence of severe hepatobiliary disease: active liver dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis.
5. Active cancer
6. Comorbidity limiting life expectancy to less than 12 months
7. Previous or ongoing evolocumab or other anti-PCSK9 therapy
8. Known hypersensitivity to any component of the trial treatment
9. Pregnant (with a positive pregnancy test at inclusion), breast-feeding or planning to have children or breast-feed during treatment and for a period of 17 weeks after the end of treatment in the trial.
10. Participating in another clinical trial with other investigational treatments or devices within 30 days prior to inclusion in this trial, or already included in a trial.
11. Unavailable and/or non-compliant to attend follow-up visits and to follow all procedures required by the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. The primary endpoint is a reduction in LDL-C levels ≥ 50% from baseline and an LDL-C level < 1.4 mmol/L at 12 months follow-up.
2. LDL-C levels will be assessed at follow-up visits at 6 and 22 weeks and 12 months after randomisation. (At 38 weeks, 16, 20, 28 and 32 months post-randomisation, only if data are available).
3. The primary clinical endpoint is the composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason at 12 months

Secondary endpoints 6

1. LDL-C<40, mg/dL at 12 months follow-up
2. Composite of death (any cause), myocardial infarction, stroke, unplanned revascularization at 12 months follow-up
3. Composite of death (any cause) or myocardial infarction at 12 months follow-up
4. Death (any cause) at 12 months follow-up
5. Death (cardiovascular) at 12 months follow-up
6. Composite of death (any cause), myocardial infarction, stroke at 12 months follow-up

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

1 Avenue Claude Vellefaux

City

Paris

Postcode

75010

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Investigator Coordonnator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Investigator Coordonnator

Locations

5 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 33 files

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

Application history

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