A study to test if tenecteplase helps people to recover from an acute stroke when given more than 4.5 hours after the person was last seen well

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-522542-40-00

WHO UTN

U1111-1323-6001

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective of the study is to test the hypothesis that i.v. tenecteplase (0.25 mg/kg, maximum 25 mg) is superior to SOC in achieving excellent functional outcome (modified Rankin Scale (mRS) score of 0-1 at Day 90) in AIS patients who were last known well >4.5 hours before randomisation (including strokes of known and unknown onset, to which wake-up strokes belong) and presenting with a significant volume of salvageable brain tissue on imaging.

Secondary objectives 1

1. The secondary objectives are to assess safety of tenecteplase in patients in this setting and efficacy in key functional outcomes.

Conditions and MedDRA coding

Acute Ischemic Stroke

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a 'Document Sharing Agreement". For study data: 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. See Section 8.1 for details.
3. Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation, last known well >4.5 h before time of presumed randomisation
4. Pre-stroke mRS ≤1 (to be assessed via medical history)
5. Imaging eligibility by MRI CT

Exclusion criteria 11

1. Intention to proceed to MT at the same site (hospital) of randomisation.
2. Occlusion of the internal carotid artery (ICA)
3. High-risk patients (increased risk of thrombolysis related hemorrhage)
4. Any intracranial hemorrhage detected on NCCT or MRI scans
5. Contra-indication to contrast brain imaging with CT and MRI
6. Severe stroke as assessed clinically (NIHSS > 25)
7. Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
8. Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
9. Patients scheduled to receive i.v. thrombolysis as standard of care
10. Other known history of or identified relevant central nervous system damage (i.e., neoplasm, arterial aneurysm and/or arterial/venous malformation, intracranial or spinal surgery) as well as known arterial aneurysm and/or arterial/venous malformations, and/or neoplasms with increased bleeding risk, located outside of the Central Nervous System.
11. Contra-indications to Tenecteplase

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. mRS 0-1 at Day 90

Secondary endpoints 6

1. mRS (ordinal) at Day 90
2. Early neurological improvement (reduction in acute – 24-hour NIHSS score of ≥8 or value of 0/1)
3. mRS 0-2 at Day 90
4. sICH as defined by SITS-MOST criteria at 36 h
5. sICH as defined by ECASS III criteria at 36 h
6. Death from any cause within 90 days

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 7

Locations

6 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Results and documents

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

Documents 107 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