StrokeNCT02229890
An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke
An observational study of Stroke, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- alteplase
- How many people
- 593 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Mar 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke within three hours after symptom onset treated at stroke centers
Who may be able to join
- Female or male inpatients
- Age 18 - 80 years
- Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan exclusion of hemorrhage
- Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment
- Stroke symptoms present for at least 30 minutes and not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder
- Patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval and storage of data and follow up procedures, according to the regulations in participating countries
- Willingness and ability to comply with the observational study protocol
Who cannot join
- Evidence of intracranial hemorrhage (ICH) on the CT-scan.
- 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
- History of previous stroke or serious head-trauma within three months
Show all 26Show fewer
- Administration of heparin within the previous 48 hours preceding the onset of stroke with an elevated activated thromboplastin time (aPTT) at presentation
- A combination of previous stroke and concomitant diabetes
- Platelet count of below 100,000/mm³
- Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (repeated IV medication) necessary to reduce BP to these limits.
- Blood glucose <50 or > 400 mg/dl
- 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)
- History or evidence or suspicion of intracranial hemorrhage including sub-arachnoid hemorrhage
- Severe uncontrolled arterial hypertension
- 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
- Bacterial endocarditis, pericarditis
- 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)
- Acute pancreatitis
- Documented ulcerative gastrointestinal disease during the last 3 months
- Arterial aneurysm, arterial/venous malformation
- Neoplasm with increased bleeding risk
- Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- Major surgery or significant trauma in past 10 days (this includes any trauma associated with current acute myocardial infarction), recent trauma to head or cranium
- Hypersensitivity to the active substance alteplase or to any of the excipients
About this study
Official title: SITS-NEW Safe Implementation of Thrombolysis in Stroke in the Non EU-World: An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke
Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute ischemic stroke
- Conditions
- Stroke
- Being tested
- alteplase
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alteplaseDrug
Also called Actilyse®
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke within three hours after symptom onset | Not described Receives: Drug: alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition)
Measured: up to 7 days
Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition)
Measured: up to 36 hours
Mortality rate
Measured: up to 6 months
Secondary outcomes (1)
Number of patients with functional independence (independence for activities of daily living)
Rankin score 0-2
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startJun 2006
- Primary completionMar 2009
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
- 593 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
- NCT02229890
- Sponsor's protocol ID
- 135.317
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SITS-NEW Safe Implementation of Thrombolysis in Stroke in the Non EU-World: An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke
- ClinicalTrials.gov ID
- NCT02229890
- Acronym / sponsor ID
- 135.317
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2009 (actual)
- First posted
- 3 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.
Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute ischemic stroke
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke within three hours after symptom onset | – | Drug: alteplase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke within three hours after symptom onset treated at stroke centers
Key inclusion criteria (7 listed)
- Female or male inpatients
- Age 18 - 80 years
- Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan exclusion of hemorrhage
- Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment
- Stroke symptoms present for at least 30 minutes and not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder
Key exclusion criteria (26 listed)
- Evidence of intracranial hemorrhage (ICH) on the CT-scan.
- 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
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 |
|---|---|---|
| alteplaseAlso: Actilyse® | Drug | Acute ischemic stroke within three hours after symptom onset |
Primary outcome
Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition)
Time frame: up to 7 days
Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition)
Time frame: up to 36 hours
Mortality rate
Time frame: up to 6 months
1 secondary outcome
Number of patients with functional independence (independence for activities of daily living)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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 7 inclusion and 26 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: finished, as of the sponsor's last update on 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition) (time frame: up to 7 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 3 Sep 2014.