Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the FICOLIN-2 Statement

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 Oct 2023 → 3 Feb 2026

Decision date (initial)

2023-08-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ANR

External identifiers

EU CT number

2023-504573-20-00

ClinicalTrials.gov

NCT05850247

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on [18F]DPA-714 PET/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis.

Secondary objectives 1

1. To assess whether plasma levels of ficolin-2 in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis correlate with: 1. morphological data : - of the plaque: presence of intraplaque hemorrhage, lipid-rich necrotic core, and thinning/rupture of the fibrous cap on carotid plaque MRI, - of the brain: infarct size, presence of hemorrhagic transformation or blood-brain barrier leakage. 2. histological data of the retrieved plaque: hemorrhagic content, lipid core, and cholesterol cleft areas, ratio between thickness of tunica media and total thickness of tunica including infiltration of cellular debris and cholesterol, rupture, intraplaque deposition of ficolin-2, macrophages and neutrophils infiltration

Conditions and MedDRA coding

stroke or transient ischemic attack

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. -Patients 18 years or over, -Signed written informed consent before any study specific intervention, -Probable ipsilateral transient ischemic attack (TIA – which involve a focal speech/language, motor or visual deficit referable to the distribution of a carotid artery and lasting less than 48 hours from the onset) OR retinal artery occlusion ≤ 48h OR ischemic stroke ≤ 48h from the onset,- Atherosclerotic carotid stenosis between 50% and 99% (NASCET method), as confirmed by one of the imaging examinations (among: Doppler ultrasound, MR angiography, CT angiography, catheter angiography) performed after index TIA or ischemic stroke- - No other identified cause of TIA, ischemic stroke or retinal artery occlusion,

Exclusion criteria 1

1. - Patients with inflammatory or autoimmune disease, hepatocellular insufficiency, acute or chronic infection, active malignancy, myocardial infarction or major surgery within the previous 30 days of index hospitalization according to the investigator, - Patients with severe renal insufficiency (estimated GFR < 30 ml/min at inclusion or known dialysis), - Patients with contraindication to MRI (agitation, claustrophobia, pacemaker, metallic (ferromagnetic) body, a known allergy to gadolinium) according to the investigator’s judgment, - Patients currently enrolled in another clinical trial including investigational medicinal products, - Female patient who is pregnant or lactating, or is of child-bearing and who did not agree to use highly effective methods of birth control throughout the study, - Patient without health coverage, - Patient under legal protection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the correlation between: - Plasma levels of ficolin-2 at day 5, - Metabolic data on [18F]DPA-714 PET/MRI: standardized uptake value (SUV) and Logan distribution volume ratio (DVR) of [18F]DPA-714 in carotids and brain at the time of the PET-Scan imaging (day 5).

Secondary endpoints 1

1. • Plasma levels of ficolin-2 at day 5 when correlating with morphological data and at day-15 when correlating with histological data, • Morphological data evaluated by the Central Image Reading Board at day 5: - on carotid plaque PET/MRI: presence of intraplaque hemorrhage, lipid-rich necrotic core, and thinning/rupture of the fibrous cap on carotid plaque MRI - on brain PET/MRI: infarct size, hemorrhagic transformation, and blood-brain barrier leakage evaluated by the Central Image Readin

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr MECHTOUFF

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr MECHTOUFF

Locations

1 EU/EEA country · 1 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 7 files

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

Application history

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