Effect of infLuenza vaccInation after Myocardial INfArction on cardiac inflammaTory responsE - a randomized, double-blind, placebo-controlled, trial (ELIMINATE trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oerebro Laen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Apr 2024 → ongoing

Decision date (initial)

2025-04-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

The primary objective is to compare influenza vaccination and placebo in reducing post myocardial infarction coronary inflammation as measured by CCTA.

Secondary objectives 3

1. To compare the differences from baseline in the average perivascular adipose tissue (PCAT) density of the whole coronary tree (main epicardial arteries ≥2mm) and the ascending aorta.
2. To compare changes in cytokine and chemokine profiles, and other markers of systemic inflammation between baseline and 8 weeks follow up in the two study groups.
3. To monitor the cardiac biomarkers at 8 weeks follow up.

Conditions and MedDRA coding

Myocardial infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients with a diagnosis of non-ST-segment elevation myocardial infarction
2. A finalized coronary PCI
3. Male or non-fertile female subjects ≥18 years (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)
4. Written informed consent
5. A CCTA scan can be scheduled within 7 days after PCI

Exclusion criteria 15

1. Has received influenza vaccination within 6 months
2. Other vaccination planned within 8 weeks (including covid-19 booster doses)
3. Severe allergy to eggs or previous allergic reaction to influenza vaccine
4. Cardiac surgery or staged PCI planned within 8 weeks
5. Coronary stent involving the proximal RCA
6. Suspicion of febrile illness or acute, ongoing infection
7. Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol
8. Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response
9. Inability to provide informed consent
10. Previous randomization in the ELIMINATE trial
11. Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.
12. Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment [eGFR <30 mL/min/1.73 m2])
13. Atrial fibrillation
14. Uncontrolled chronic inflammatory disease
15. Unable to comply with protocol requirements

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in pericoronary adipose tissue (PCAT) density (right coronary artery), a marker of coronary artery inflammation measured by CCTA, at week 8.

Secondary endpoints 5

1. Change from baseline in the average PCAT density of the whole coronary tree (main epicardial arteries ≥2mm)
2. Change from baseline in the perivascular adipose tissue density of the ascending aorta
3. Differences in cytokine and chemokine profiles (including IL-1β, TNF-α, IL-2r, IL-6), and other markers of systemic inflammation, (ferritin and high sensitivity CRP) at baseline and 8 weeks follow up
4. Cardiac biomarkers (troponin-I, N-terminal pro-B-type natriuretic peptide) at 8 weeks follow up
5. Exploratory endpoints: Differences in myeloid, T- and B cell subpopulations, their activation status and their gene expression signatures, measured by mass cytometry and single-cell RNA sequencing, and differences in blood proteome, from baseline to 8 weeks.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oerebro Laen

Sponsor organisation

Region Oerebro Laen

Address

Sodra Grev Rosengatan

City

Orebro

Postcode

701 85

Country

Sweden

Scientific contact point

Organisation

Region Oerebro Laen

Contact name

Sara Cajander

Public contact point

Organisation

Region Oerebro Laen

Contact name

Sara Cajander

Locations

2 EU/EEA countries · 2 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 11 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