Stroke Clinical Trial
Official title:
Protocol for Post Marketing Surveillance of Actilyse Vial
NCT number | NCT02229799 |
Other study ID # | 135.315 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | August 28, 2014 |
Last updated | August 28, 2014 |
Start date | February 2003 |
Verified date | August 2014 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry of Food and Drug Safety |
Study type | Observational |
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
Status | Terminated |
Enrollment | 265 |
Est. completion date | |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 79 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical effectiveness assessed by 30 days-mortality | 30 days | No | |
Primary | Number of patients with adverse events | up to 30 days | No | |
Primary | Number of patients with clinically significant abnormal findings in physical examination | up to 30 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Suspended |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |