acute ischemic stroke MedDRA version: 9.1 Level: LLT Classification code 10043647 Term: Thrombotic stroke
Conditions
Interventions
Trade Name: ACTILYSE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Alteplase
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentr
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female or male inpatients - Age > 80 years. - Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage. - Onset of symptoms =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Evidence of intracranial haemorrhage on the CT-scan. - Symptoms of ischemic attack began more than 3 hours prior to infusion start or when time of symptom onset is unknown. - Minor neurological deficit or symptoms rapidly improving before start of infusion. - Severe stroke as assessed clinically (e.g. NIHSS>17) and/or by appropriate imaging techniques. - Epileptic seizure at onset of stroke - Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal. - Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory. - Prior stroke within the last 3 months - Patients with any history of prior stroke and concomitant diabetes - Platelet count of below 100,000/mm3. - Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP below these limits. - Blood glucose 200 mg/dl; values up to 300 mg/dl are allowed, if they can be reduced to < 200 mg/dl before treatment. - Known haemorrhagic diathesis - Patients receiving oral anticoagulants, e.g. warfarin sodium - Manifest or recent severe or dangerous bleeding - Known history of diagnosed or suspected intracranial haemorrhage - Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) - History of Haemorrhagic retinopathy - Recent (less than 10 days) traumatic external heart massage - Recent (less than 10 days) puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture). - Known current bacterial endocarditis, pericarditis. - Acute pancreatitis - Documented ulcerative gastrointestinal disease during the last 3 months - Documented oesophageal varices - Documented arterial- aneurysm, arterial/venous malformation - Neoplasm with increased bleeding risk - Severe liver disease, including hepatic failure, cirrhosis, portal hypertension - Major surgery or significant trauma in past 3 months - Current or recent (within 3 months) participation in another investigational drug treatment protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect efficacy and safety data on alteplase (rt-PA) in patients aged more than 80 years old, to demonstrate that the treatment of these patients within 3 hours of onset of symptoms of acute ischemic stroke with rt PA compared to patients receiving standard treatment, will result in an improved clinical outcome with a favourable benefit/risk ratio;Secondary Objective: - Study efficacy measures along 90 days; - Study prognostic factors; - Set, in this patient population, a neurological severity cut-off point, if any, below which, benefit/risk ratio of thrombolityc therapy is advantageous;Primary end point(s): Patients (%) with favourable outcome at day 90, according to: modified Rankin Scale (mRS) 0-2 | — |
Countries
Italy
Outcome results
None listed