Acute Stroke Study of Optimized tPA Dosing in Correlation with Artery Status - SOTADAS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003371-53-CZ

Enrollment

Unknown

Registered

2008-07-22

Start date

2008-08-08

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute ischemic stroke with proven occlusion of major brain arteries demonstrated by transcranial ultrasound. MedDRA version: 9.1 Level: LLT Classification code 10059620 Term: Plasminogen activator inhibitor

Interventions

Trade Name: Actilyse Pharmaceutical Form: Powder and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: male or female >18 year old, the diagnosis of acute ischemic stroke, presence of meaningful neurological deficit (NIHSS>4), initiation of treatment within 3 hours from symptom onset, meets general criteria for tPA administration, occlusion of major brain arteries demonstrated by TCD, and signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria are: absent insonation window (despite echocontrast use), pregnant or breast-feeding females, patients receiving other experimental drugs or therapies prior 30 days of study treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to provide information on the safety and activity of intravenous tissue plasminogen activator in the dose guided by artery status on transcranial ultrasound or transcranial color coded duplex ultrasound. ;Secondary Objective: The secondary objective is to provide preliminary data on clinical efficacy measured as National Institute of Health Stroke Scale and modified Rankin scale at 3 month.;Primary end point(s): The primary safety endpoint is the symptomatic intracerebral hemorhage on CT 24-36 hours post-treatment defined as parenchymal hemorrhage type 2 accompanied by neurological worsening by =4 points in NIHSS that is related to the ICH based on the opinion of the investigator. The primary activity endpoint is the proportion of the subject achieving complete recanalization at 120 minutes on transcranial ultrasound.	—

Measure

Time frame

Main Objective: The primary objective of the study is to provide information on the safety and activity of intravenous tissue plasminogen activator in the dose guided by artery status on transcranial ultrasound or transcranial color coded duplex ultrasound. ;Secondary Objective: The secondary objective is to provide preliminary data on clinical efficacy measured as National Institute of Health Stroke Scale and modified Rankin scale at 3 month.;Primary end point(s): The primary safety endpoint is the symptomatic intracerebral hemorhage on CT 24-36 hours post-treatment defined as parenchymal hemorrhage type 2 accompanied by neurological worsening by =4 points in NIHSS that is related to the ICH based on the opinion of the investigator. The primary activity endpoint is the proportion of the subject achieving complete recanalization at 120 minutes on transcranial ultrasound.

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026