Protocol for Post Marketing Surveillance of Actilyse Vial

Launched by BOEHRINGER INGELHEIM · Aug 28, 2014

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Eligibility criteria

• Inclusion Criteria:
• • All in/out patients diagnosed as acute ischemic stroke
• Exclusion Criteria:
• 1. Actilyse should not be administered to patients with high risk as follows:
• • Significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis
• • Patients receiving oral anticoagulants, e.g. warfarin sodium (INR \> 1.3)
• • Manifest bleeding or recent severe or dangerous bleeding
• • History or evidence or suspicion of intracranial hemorrhage including sub-arachnoid hemorrhage
• • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
• • Hemorrhagic retinopathy (e.g. in diabetes, vision disturbances may indicate hemorrhagic retinopathy) or other hemorrhagic ophthalmic conditions
• • Prolonged or traumatic cardiopulmonary resuscitation (\> 2 minutes), obstetrical delivery, within the past 10 days, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
• • Severe uncontrolled arterial hypertension
• • Bacterial endocarditis or pericarditis
• • Acute pancreatitis
• • Documented ulcerative gastrointestinal disease within the past 3 months, oesophageal varices, arterial-aneurysms, or arterial/venous malformations
• • Neoplasm with increased bleeding risk
• • Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
• • Hypersensitive to the active substance alteplase or to any of the excipients
• • 2. In cases of acute myocardial infarction and acute pulmonary embolism, any history of stroke should be contraindicated.
• 3. In case that Actilyse is administered to acute ischaemic stroke, the followings should be contraindicated:
• • Symptoms of ischemic attack began more than 3 hours prior to infusion start or when time of symptom onset is unknown,
• • Symptoms of acute ischemic stroke that were either rapidly improving or only minor before start of infusion
• • Severe stroke as assessed clinically and/or by appropriate imaging techniques,
• • Seizure at onset of stroke
• • Evidence of intracranial hemorrhage (ICH) on the CT-scan
• • Symptoms suggestive of subarachnoid hemorrhage, even if CT-scan is normal
• • Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated partial thromboplastin time (aPTT) at presentation
• • A combination of previous stroke and diabetes mellitus
• • Prior stroke or head trauma within the past 3 months
• • Platelet count of less than 100,000/mm3
• • Systolic blood pressure\>185 mm Hg, or diastolic blood pressure\>110 mm Hg, or aggressive management (IV medication) is necessary to reduce blood pressure to these limits
• • Blood glucose\<50mg/dl or \>400 mg/dl
• • 4. Acute stroke patients between the age of ≤ 18 or ≥ 80 years