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Protocol for Post Marketing Surveillance of Actilyse Vial

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ClinicalTrials.gov Identifier: NCT02229799
Recruitment Status : Terminated
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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. 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

Condition or disease Intervention/treatment
Stroke Drug: Actilyse

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Study Type : Observational
Actual Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for Post Marketing Surveillance of Actilyse Vial
Study Start Date : February 2003
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Group/Cohort Intervention/treatment
Stroke patients Drug: Actilyse



Primary Outcome Measures :
  1. Clinical effectiveness assessed by 30 days-mortality [ Time Frame: 30 days ]
  2. Number of patients with adverse events [ Time Frame: up to 30 days ]
  3. Number of patients with clinically significant abnormal findings in physical examination [ Time Frame: up to 30 days ]


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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with acute ischemic stroke
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02229799     History of Changes
Other Study ID Numbers: 135.315
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action