Trials Sponsors Conditions Drugs Pricing

Conditions

acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation

Secondary Outcomes (13)

Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days
Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days
Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours
Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days
Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days
+8 more secondary outcomes

Interventions

Metalyse 5 000 units (25 mg) powder for solution for injectionType not reported

Placebo to Metalyse®Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Metalyse 5 000 units (25 mg) powder for solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Metalyse 5 000 units (25 mg) powder for solution for injection
Named ingredient: Tenecteplase
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years
Clinical diagnosis of acute stroke with disabling deficit
National Institutes of Health Stroke Scale (NIHSS) score at least 2

Sponsors & Collaborators

University Medical Center Hamburg-Eppendorf
Type not reportedlead

Study Sites (43)

Technische Universitaet Dresden

Dresden, 01307, Germany

Timo Siepmann035145818578 timo.siepmann@ukdd.de

Kamillus Klinik Asbach gGmbH

Asbach, 53567, Germany

Julian Zimmermann0268359621 Julian.zimmermann@kamillus-klinik.de

Klinikum Osnabrueck GmbH

Osnabrueck, 49076, Germany

Martina Petersen05414056564

Central Study Contacts

Senior Physician at the Department of Neurology

+4915222898447 passion-trial@uke.de

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

October 1, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521762-99-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:20:14 UTC

Documents

D4_DE_Patient Facing Documents_PROMIS-10_de

Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations