Protocol for Post Marketing Surveillance of Actilyse Vial

NCT02229799 | Terminated

• 1 other identifier: 135.315
• Study Type: observational
• Target: 265
• Locations: 0 countries
• Sites: N/A

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 investigating followings;

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Clinical effectiveness assessed by 30 days-mortality

  30 days

• Number of patients with adverse events

  up to 30 days

• Number of patients with clinically significant abnormal findings in physical examination

  up to 30 days

Study Arms (1)

Stroke patients

Drug: Actilyse

Interventions

Actilyse DRUG

Stroke patients

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute ischemic stroke

You may qualify if:

• All in/out patients diagnosed as acute ischemic stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: February 1, 2003
• Primary Completion: December 1, 2004
• Last Updated: September 1, 2014

Record last verified: 2014-08