StrokeNCT02229799
Protocol for Post Marketing Surveillance of Actilyse Vial
An observational study of Stroke, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- Actilyse
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Dec 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute ischemic stroke
Who may be able to join
- All in/out patients diagnosed as acute ischemic stroke
Who cannot join
- 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)
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- 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
About this study
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;
- Unknown adverse events (especially serious adverse events)
- Frequency (Incidence) and trend of adverse events under the actual practice
- Factors on the safety profile of Actilyse
- Factors on the efficacy profile of Actilyse
- Conditions
- Stroke
- Being tested
- Actilyse
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActilyseDrug
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Not described Receives: Drug: Actilyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness assessed by 30 days-mortality
Measured: 30 days
Number of patients with adverse events
Measured: up to 30 days
Number of patients with clinically significant abnormal findings in physical examination
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startFeb 2003
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229799
- Sponsor's protocol ID
- 135.315
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Post Marketing Surveillance of Actilyse Vial
- ClinicalTrials.gov ID
- NCT02229799
- Acronym / sponsor ID
- 135.315
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Dec 2004 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Unknown adverse events (especially serious adverse events)
- Frequency (Incidence) and trend of adverse events under the actual practice
- Factors on the safety profile of Actilyse
- Factors on the efficacy profile of Actilyse
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Drug: Actilyse |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute ischemic stroke
Key inclusion criteria (1 listed)
- All in/out patients diagnosed as acute ischemic stroke
Key exclusion criteria (30 listed)
- Actilyse should not be administered to patients with high risk as follows:
- 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:
- Acute stroke patients between the age of ≤ 18 or ≥ 80 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actilyse | Drug | Stroke patients |
Primary outcome
Clinical effectiveness assessed by 30 days-mortality
Time frame: 30 days
Number of patients with adverse events
Time frame: up to 30 days
Number of patients with clinically significant abnormal findings in physical examination
Time frame: up to 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness assessed by 30 days-mortality (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.