Local Tenecteplase ApplicatiOn subsequent to endovasCular Recanalization in Anterior CircuLation Stroke - the LOCAL trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Heidelberg AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

30 Mar 2026 → ongoing

Decision date (initial)

2025-10-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To investigate whether supplementary intra-arterial administration of thrombolysis (Tenecteplase) after successful endovascular recanalization of anterior circulation ischemic stroke results in improved clinical outcome evaluated based on the proportion of patients with an excellent clinical outcome of mRS 0 – 1 after 90 days +/- 15 days

Secondary objectives 7

1. To investigate whether supplementary intra-arterial administration of thrombolysis (Tenecteplase) after successful endovascular recanalization of anterior circulation ischemic stroke results in improved recanalization grade, clinical outcome, neurological symptoms, performance in activities of daily living, cognitive status and quality of life evaluated on the basis of • the proportion of patients with a very good clinical outcome of mRS of 0 – 2 after 90 +/- 15 days
2. shift in mRS after 90 days
3. absolute change in NIHSS at 24+/- 6h postrandomization
4. normalized change in NIHSS at 24+/- 6h postrandomization
5. EQ-5D-5L score after 90 +/- 15 days
6. MoCA after 90 +/- 15 days
7. infarct volume (exploratory)

Conditions and MedDRA coding

acute ischemic stroke

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (distal ICA, Carotid-T, M1 or proximal M2 occlusion) should be confirmed by either CT or MRI and must be proven by catheter angiographic run prior to mechanical recanalization.
2. Successful recanalization (eTICI≥ 2b50) of intracranial artery occlusion (as per definition by the interventionalist).
3. Estimated time between stroke onset / last seen well and study procedure of < 24 hours
4. No relevant pre-stroke functional disability (pre-morbid mRS of 0 – 1)
5. Neurological deficit with a NIHSS of ≥ 4 and ≤ 25 at baseline prior to thrombectomy
6. Age ≥ 18
7. ASPECTS ≥ 6 on baseline non-contrast CT or ASPECTS ≥ 5 on diffusion weighted MRI

Exclusion criteria 15

1. Treatment with intravenous rt-pA (alteplase) thrombolysis at study site or intravenous TNK (tenecteplase) within 1 h before randomization
2. Notably increased risk of intracranial hemorrhage
3. Dissection of the extra- or intracranial cerebral arteries
4. Major surgery or any severe bleeding in the past month
5. Thrombocytopenia (Platelet count < 100,000)
6. Insufficient command of the German language, if this can be reliably determined prior to enrolment.
7. Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)
8. Pregnant or breast-feeding women
9. Known severe illness with life expectancy less than 12 months
10. Participating in another clinical trial that could confound the treatment or outcomes of this investigation
11. Hypersensitivity to the active substance (Tenecteplase), to any other excipients or to gentamicin or know allergy against alteplase
12. Pre-existing stenosis in the target vessel requiring stent therapy
13. Tandem occlusions of both cervical and intracranial vessels
14. Acute or prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure
15. Any efforts to control non-controlled hypertension after thrombectomy and before trial inclusion exceed 10 minutes

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To investigate whether supplementary intra-arterial administration of thrombolysis (Tenecteplase) after successful endovascular recanalization of anterior circulation ischemic stroke results in improved clinical outcome evaluated based on the proportion of patients with an excellent clinical outcome of mRS 0 – 1 after 90 days +/- 15 days

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Heidelberg AöR

Sponsor organisation

Universitaetsklinikum Heidelberg AöR

Address

Im Neuenheimer Feld 672, Neuenheim Neuenheim

City

Heidelberg

Postcode

69120

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Heidelberg AöR

Contact name

Prof. Dr. med. Markus Möhlenbruch

Public contact point

Organisation

Universitaetsklinikum Heidelberg AöR

Contact name

Prof. Dr. med. Markus Möhlenbruch

Third parties 2

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 21 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