Protocol for Post Marketing Surveillance of Actilyse Vial

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 investigating followings;

1. Unknown adverse events (especially serious adverse events)
2. Frequency (Incidence) and trend of adverse events under the actual practice
3. Factors on the safety profile of Actilyse
4. Factors on the efficacy profile of Actilyse

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Drug: Actilyse

• Study Type: Observational
• Enrollment (Actual): 265

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with acute ischemic stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke patients	Drug: Actilyse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 30 days
Clinical effectiveness assessed by 30 days-mortality	30 days
Number of patients with clinically significant abnormal findings in physical examination	up to 30 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (ACTUAL): December 1, 2004

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (ESTIMATE): September 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: 135.315