Intra-arterial thrombolysis after SUCCESSful reperfusion of acute ischemic stroke

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHRU De Nancy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

1 Jun 2025 → ongoing

Decision date (initial)

2024-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

This study is funded by the French DGOS as part of the national PHRC 2020.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy, Pharmacoeconomic

To demonstrate the superiority of adjunct IA thrombolysis versus no adjunct IA thrombolysis on 90-day functional outcome rate (shift of 90-day modified Rankin Scale [mRS] toward a better functional outcome) in patients with acute anterior circulation LVO stroke who have successful angiographic reperfusion (eTICI 2b-2c-3) after IVT alone, bridging therapy, or MT alone.

Secondary objectives 3

1. 1. To assess the clinical and safety of adjunct IA thrombolysis after IVT alone, bridging therapy, or MT alone.
2. 2. To assess the cost-effectiveness of adjunct IA thrombolysis after IVT alone, bridging therapy, or MT alone.
3. 3. To assess the budget impact of new stroke management strategy in case of successful angiographic reperfusion.

Conditions and MedDRA coding

Ischemic stroke

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • Pre-stroke mRS 0-2
2. • Acute ischemic stroke with anterior circulation LVO defined as intracranial internal carotid artery, M1, or M2 occlusion proven on CT or MRI
3. • NIHSS score ≥ 5 at admission
4. • eTICI 2b-2c-3 after IVT alone, bridging therapy (IVT + MT), or MT alone and confirmed by catheter angiogram

Exclusion criteria 4

1. • Contraindications for IA thrombolysis: Platelet count <100 000/mm3, INR >1.7, AOD use <48h or biological confirmation of activity and effective heparin treatment
2. • Intracerebral hemorrhage
3. • Occlusion or high grade stenosis treated by stenting
4. • Patient expected to be unable to present or be available for 3-month visit follow-up

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the severity of disability according to the shift of scores on the modified Rankin Scale (mRS) at 90 (±15) days.

Secondary endpoints 12

1. 1a) EFFICACY: -Distribution of the mRS score at day 90 (±15).
2. 1a) EFFICACY: -Excellent functional outcome (mRS 0-1) at 90 (±15) day.
3. 1a) EFFICACY: -Functional independence (mRS 0-2) at 90 (±15) day.
4. 1a) EFFICACY: -Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1) at 24 (±6) hours.
5. 1a) EFFICACY: -eTICI at the end of endovascular procedure (including IA thrombolysis in the intervention group).
6. 1a) EFFICACY: -Infarct growth: difference in (i) ASPECTS scores and (ii) infarct core volume (MRI DWI or CT perfusion) between 24 (±6) hours and baseline
7. 1b) SAFETY: -Complications during endovascular treatment: arterial perforation, extracranial carotid dissection, embolization in a new territory.
8. 1b) SAFETY: -Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on CT or MRI, according to the Heidelberg classification (imaging core laboratory).
9. 1b) SAFETY: -Extracranial hemorrhage requiring transfusion, surgery or resulting in death
10. 1b) SAFETY: -Death from all causes within 90 (±15) days
11. 2) COST EFFECTIVENESS: Incremental cost-effectiveness and cost-utility ratios of a strategy based on adjunct IA thrombolysis in case of successful angiographic reperfusion compared with a strategy of no adjunct IA thrombolysis.
12. 3) TOTAL COST: Total cost of each treatment strategy and net impact on the National Health Insurance System (difference in costs).

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHRU De Nancy

Sponsor organisation

CHRU De Nancy

Address

Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034

City

Nancy Cedex

Postcode

54035

Country

France

Scientific contact point

Organisation

CHRU De Nancy

Contact name

Benjamin GORY

Public contact point

Organisation

CHRU De Nancy

Contact name

Benjamin GORY

Locations

1 EU/EEA country · 27 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 19 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