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sistemic thrombolysis with Alteplase between 3-4.5 hours in acute ischaemic stroke. Evaluation of clinical efficacy - ND

sistemic thrombolysis with Alteplase between 3-4.5 hours in acute ischaemic stroke. Evaluation of clinical efficacy - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012654-20-IT
Enrollment
Unknown
Registered
2009-05-26
Start date
2009-07-29
Completion date
Unknown
Last updated
2014-02-10

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

Conditions

Ischaemic stroke MedDRA version: 9.1 Level: PT Classification code 10014498 MedDRA version: 9.1 Level: PT Classification code 10043647

Interventions

Trade Name: ACTILYSE*IV FL 50MG+FL 50ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: ALTEPLASI Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentrati

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - ischaemic stroke between 3-4.5 hours from onset 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: - contraindication of thrombolysis

Design outcomes

Primary

MeasureTime frame
Main Objective: Efficacy and safety;Secondary Objective: nd;Primary end point(s): favorable outcome as measured by modified Rankin Scale 0-2—

Countries

Italy

Outcome results

None listed

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