Status:
TERMINATED
Protocol for Post Marketing Surveillance of Actilyse Vial
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Stroke
Eligibility:
All Genders
19-79 years
Brief Summary
The objectives of this study are to review the safety and efficacy of Actilyse Vial (hereafter referred to as "Actilyse") in post-marketing use for treatment of acute ischemic stroke, through investig...
Eligibility Criteria
Inclusion
- All in/out patients diagnosed as acute ischemic stroke
Exclusion
- 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
- In cases of acute myocardial infarction and acute pulmonary embolism, any history of stroke should be contraindicated.
- 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
- Acute stroke patients between the age of ≤ 18 or ≥ 80 years
Key Trial Info
Start Date :
February 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT02229799
Start Date
February 1 2003
Last Update
September 1 2014
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