EUCTR2007-006177-88-ITActive, not recruitingNot Applicable
A randomized controlled trial of alteplase (rt-PA) vs standard treatment in acute ischemic hemispheric stroke in patients aged more than 80 years where thrombolysis is initiated within 3 hours after stroke onset - ND
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA0 sitesStarted: February 8, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 < 3 hours prior to initiation of administration of study drug. - Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder. - Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centres
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •- 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 <50 or > 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
Investigators
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