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Randomized,controlled,open study to evaluate the response to r-TPA therapy vs clinical standard therapy in patients affected by ictus at awakening coming in ER within 3 hours from symptoms compare. - ND

Randomized,controlled,open study to evaluate the response to r-TPA therapy vs clinical standard therapy in patients affected by ictus at awakening coming in ER within 3 hours from symptoms compare. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019359-23-IT
Enrollment
Unknown
Registered
2010-03-22
Start date
2010-04-01
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

patients affected by ictus at awakening coming in ER within 3 hours from symptoms compare MedDRA version: 9.1 Level: LLT Classification code 10042244

Interventions

Trade Name: ACTILYSE*IV FL 20MG+FL 20ML Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: alteplase Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients aged between 18 and 80 years old; diagnosis of ischemic ictus with exclusion by TC of bleeding; neurologic dificit evaluable with NIHSS (= 3, = 25);no sponstaneous improvement; symptoms onset =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patients allergic to one or more of the composes of the drug; patients affected by mild or severe renal impairment GFR/eGFR < 60mL/min; patients unable to perform RM; patients with severe claustrophobia.

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the efficacy and tolerability of r-TPA therapy in patients with ictus at awakening;Secondary Objective: to find out the clinical and radiologic features to support the therapeutic response in patients with ictus at awakening;Primary end point(s): Functional indipendence at 3 months (point < equal to 2 to MRS)—

Countries

Italy

Outcome results

None listed

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