Tenecteplase in Wake-up Ischaemic Stroke Trial "TWIST"
Recruiting
Phase 3 Results N/AUpdate History
24 Feb '18 |
A location was updated in København. New The overall status was updated to "Recruiting" at Rigshospitalet. A location was updated in København. New The overall status was updated to "Recruiting" at Bispebjerg hospital. A location was updated in Tartu. New The overall status was updated to "Recruiting" at Tartu University Clinic. A location was updated in Helsinki. New The overall status was updated to "Recruiting" at Helsinki University Hospital. A location was updated in Vilnius. New The overall status was updated to "Recruiting" at Vilnius University Hospital. A location was updated in Drammen. New The overall status was updated to "Recruiting" at Drammen sykehus Vestre Viken HF. A location was updated in Flekkefjord. New The overall status was updated to "Recruiting" at Sørlandet Sykehus HF Flekkefjord. A location was updated in Førde. New The overall status was updated to "Recruiting" at Helse Førde HF. A location was updated in Gravdal. New The overall status was updated to "Recruiting" at Nordlandssykehuset Lofoten Gravdal. A location was updated in Hammerfest. New The overall status was updated to "Recruiting" at Helse Finnmark Hammerfest. A location was updated in Harstad. New The overall status was updated to "Recruiting" at University Hospital of North Norway, Harstad. A location was updated in Kirkenes. New The overall status was updated to "Recruiting" at Helse Finnmark HF Kirkenes. A location was updated in Lørenskog. New The overall status was updated to "Recruiting" at Akershus universitetssykehus (Ahus). A location was updated in Mosjøen. New The overall status was updated to "Recruiting" at Helgelandssykehuset Mosjøen. A location was updated in Narvik. New The overall status was updated to "Recruiting" at University Hospital of North Norway, Narvik. A location was updated in Sandvika. New The overall status was updated to "Recruiting" at Bærum sykehus Vestre Viken HF. A location was updated in Skien. New The overall status was updated to "Recruiting" at Sykehuset Telemark Skien. A location was updated in Stavanger. New The overall status was updated to "Recruiting" at Stavanger Universitetssjukehus. A location was updated in Trondheim. New The overall status was updated to "Recruiting" at St Olavs Hospital. A location was updated in Göteborg. New The overall status was updated to "Recruiting" at Sahlgrenska Universitetssjukhuset. A location was updated in Hässleholm. New The overall status was updated to "Recruiting" at Hässleholm Sjukhus. A location was updated in Solna. New The overall status was updated to "Recruiting" at Karolinska sjukhuset. A location was updated in Uppsala. New The overall status was updated to "Recruiting" at Akademiska Sjukhuset. A location was updated in Basel. New The overall status was updated to "Recruiting" at University Hospital Basel. |
21 Jul '17 |
The Summary of Purpose was updated. New
Stroke is a leading causes of death and disability. At least 20% of strokes occur during
sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is
effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom
onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy.
Previous studies indicate that many wake-up strokes occur just before awakening.
In this study, patients with wake-up stroke will be randomized to thrombolysis with
tenecteplase and best standard treatment or to best standard treatment without thrombolysis.
Tenecteplase has several potential advantages over alteplase, including very rapid action and
that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done
to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT
scan to inform this decision. CT is used as a routine examination in all stroke patients.
Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more
complex brain scans, which are not routinely available in the emergency situation in all
hospitals.
Old
Stroke is a leading causes of death and disability. At least 20% of strokes occur during
sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is
effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom
onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy.
Previous studies indicate that many wake-up strokes occur just before awakening.
In this study, patients with wake-up stroke will be randomized to thrombolysis with
tenecteplase and best standard treatment or to best standard treatment without thrombolysis.
Tenecteplase has several potential advantages over alteplase, including very rapid action
and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be
done to exclude bleeding or significant brain damage as a result from the stroke. We will
use a CT scan to inform this decision. CT is used as a routine examination in all stroke
patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase
and more complex brain scans, which are not routinely available in the emergency situation
in all hospitals.
The description was updated. New
Background:
One in five strokes occur during sleep, but patients with "wake-up" stroke are not given
thrombolytic therapy because time of stroke onset is unknown. On-going trials are testing
alteplase, and use MRI techniques for selection of patients. Tenecteplase has many
pharmacological advantages over alteplase: greater fibrin specificity, very rapid action,
longer half-life, and single bolus administration. In addition, patient selection based on
MRI findings risks excluding many patients that might otherwise benefit. TWIST will test
tenecteplase and will not use MRI techniques for selection of patients. Plain CT and CT
angiography (if possible) will be performed before randomisation, and CT perfusion will be
performed at selected centres, as part of a sub-study.
Study design: TWIST is an international, multi-centre, randomised, open-label,
blinded-endpoint trial of tenecteplase for acute ischaemic 'wake-up' stroke.
Study questions:
1. Can tenecteplase given <4.5 hours of awakening improve functional outcome at 3 months?
2. Can findings on cerebral plain CT and CT angiography (and CT perfusion, at selected
centres) identify patients who benefit from such treatment, compared to other patients?
Patients eligible for treatment who are able to receive tenecteplase within 4.5 hours of
waking, will be randomly allocated to treatment with tenecteplase in addition to best
standard treatment, versus best standard treatment.
Randomisation and treatment: Central randomisation (over the internet) to tenecteplase 0.25
mg/mg i.v. (maximum dose 25 mg) plus best medical treatment vs. best medical treatment alone.
Imaging: All patients will undergo CT and CT angiography (CTA, if possible) before
randomisation and on day 2. CT perfusion (CTP) will be performed at selected centres, as part
of a sub-study.
Follow-up and primary effect variable: Centralised follow-up via telephone or mail at 3
months. The primary effect variable is functional outcome (modified Rankin Scale score).
Study size and centers: 500 patients from centers in Norway, Sweden, Denmark, Finland,
Estonia, Lithuania, United Kingdom and Switzerland.
Old
Background:
One in five strokes occur during sleep, but patients with "wake-up" stroke are not given
thrombolytic therapy because time of stroke onset is unknown. On-going trials are testing
alteplase, and use MRI techniques for selection of patients. Tenecteplase has many
pharmacological advantages over alteplase: greater fibrin specificity, very rapid action,
longer half-life, and single bolus administration. In addition, patient selection based on
MRI findings risks excluding many patients that might otherwise benefit. TWIST will test
tenecteplase and will not use MRI techniques for selection of patients. Plain CT and CT
angiography (if possible) will be performed before randomisation, and CT perfusion will be
performed at selected centres, as part of a sub-study.
Study design: TWIST is an international, multi-centre, randomised, open-label,
blinded-endpoint trial of tenecteplase for acute ischaemic 'wake-up' stroke.
Study questions:
1. Can tenecteplase given <4.5 hours of awakening improve functional outcome at 3 months?
2. Can findings on cerebral plain CT and CT angiography (and CT perfusion, at selected
centres) identify patients who benefit from such treatment, compared to other patients?
Patients eligible for treatment who are able to receive tenecteplase within 4.5 hours of
waking, will be randomly allocated to treatment with tenecteplase in addition to best
standard treatment, versus best standard treatment.
Randomisation and treatment: Central randomisation (over the internet) to tenecteplase 0.25
mg/mg i.v. (maximum dose 25 mg) plus best medical treatment vs. best medical treatment
alone.
Imaging: All patients will undergo CT and CT angiography (CTA, if possible) before
randomisation and on day 2. CT perfusion (CTP) will be performed at selected centres, as
part of a sub-study.
Follow-up and primary effect variable: Centralised follow-up via telephone or mail at 3
months. The primary effect variable is functional outcome (modified Rankin Scale score).
Study size and centers: 500 patients from centers in Norway, Sweden, Denmark, Finland,
Estonia, Lithuania, United Kingdom and Switzerland.
The eligibility criteria were updated. New
Inclusion Criteria:
- Stroke symptoms on awakening that were not present before sleep
- Clinical diagnosis of stroke with limb weakness with NIHSS score >5, or dysphasia
- Treatment with tenecteplase is possible within 4.5 hours of awakening
- Written consent from the patient, non-written consent from the patient (witnessed by
non-participating health care personnel), or written consent from the nearest family
member
Exclusion Criteria:
- Age <18 years
- NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
- Findings on plain CT that indicate that the patient is unlikely to benefit from
treatment:
- Infarction comprising more than >1/3 of the middle cerebral artery territory on
plain CT or CT perfusion
- Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g
cerebral tumour)
- Patient will be treated with intra-arterial interventions for proximal cerebral artery
occlusion
- Active internal bleeding of high risk of bleeding, e.g.:
- Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the
previous 21 days, or arterial puncture at a non-compressible site within the
previous 7 days
- Any known defect in coagulation, e.g. current use of vitamin K antagonist with an
INR >1.7 or prothrombin time >15 seconds, or use of direct thrombin inhibitors or
direct factor Xa inhibitors during the last 24 hours (unless reversal of effect
can be achieved by agents such as idarucizumab or andexanet) or with elevated
sensitive laboratory tests (such as activated partial thromboplastin time (aPTT),
international normalized ratio (INR), platelet count, ecarin clotting time,
thrombin time (TT), or appropriate factor Xa activity assays), or heparins during
the last 24 hours or with an elevated aPTT greater than the upper limit of normal
- Known defect of clotting or platelet function or platelet count below 100,000/mm3
(but patients on antiplatelet agents can be included)
- Ischaemic stroke or myocardial infarction in previous 3 months, previous
intracranial haemorrhage, severe traumatic brain injury or intracranial or
intraspinal operation in previous 3 months, or known intracranial neoplasm,
arteriovenous malformation or aneurysm
- Contraindications to tenecteplase, e.g., acute bacterial endocarditis or pericarditis;
acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis,
portal hypertension; active hepatitis; systemic cancer with increased bleeding risk;
haemostatic defect including secondary to severe hepatic, renal disease; organ biopsy;
prolonged cardiopulmonary resuscitation > 2 min (within 2 weeks)
- Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg),
despite blood pressure lowering treatment
- Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices is
acceptable)
- Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding.
In any woman of childbearing potential, a pregnancy test must be performed and the
result assessed before trial entry
- Other serious or life-threatening disease before the stroke: severe mental or physical
disability (e.g. Mini Mental Status score <20, or mRS score ≥3), or life expectancy
less than 12 months
- Patient unavailability for follow-up (e.g. no fixed address)
Old
Inclusion Criteria:
- Stroke symptoms on awakening that were not present before sleep
- Clinical diagnosis of stroke with limb weakness with NIHSS score >5, or dysphasia
- Treatment with tenecteplase is possible within 4.5 hours of awakening
- Written consent from the patient, non-written consent from the patient (witnessed by
non-participating health care personnel), or written consent from the nearest family
member
Exclusion Criteria:
- Age <18 years
- NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
- Findings on plain CT that indicate that the patient is unlikely to benefit from
treatment:
- Infarction comprising more than >1/3 of the middle cerebral artery territory on
plain CT or CT perfusion
- Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g
cerebral tumour)
- Patient will be treated with intra-arterial interventions for proximal cerebral
artery occlusion
- Active internal bleeding of high risk of bleeding, e.g.:
- Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within
the previous 21 days, or arterial puncture at a non-compressible site within the
previous 7 days
- Any known defect in coagulation, e.g. current use of vitamin K antagonist with
an INR >1.7 or prothrombin time >15 seconds, or use of direct thrombin
inhibitors or direct factor Xa inhibitors during the last 24 hours (unless
reversal of effect can be achieved by agents such as idarucizumab or andexanet)
or with elevated sensitive laboratory tests (such as activated partial
thromboplastin time (aPTT), international normalized ratio (INR), platelet
count, ecarin clotting time, thrombin time (TT), or appropriate factor Xa
activity assays), or heparins during the last 24 hours or with an elevated aPTT
greater than the upper limit of normal
- Known defect of clotting or platelet function or platelet count below
100,000/mm3 (but patients on antiplatelet agents can be included)
- Ischaemic stroke or myocardial infarction in previous 3 months, previous
intracranial haemorrhage, severe traumatic brain injury or intracranial or
intraspinal operation in previous 3 months, or known intracranial neoplasm,
arteriovenous malformation or aneurysm
- Contraindications to tenecteplase, e.g., acute bacterial endocarditis or
pericarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic
failure, cirrhosis, portal hypertension; active hepatitis; systemic cancer with
increased bleeding risk; haemostatic defect including secondary to severe hepatic,
renal disease; organ biopsy; prolonged cardiopulmonary resuscitation > 2 min (within
2 weeks)
- Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg),
despite blood pressure lowering treatment
- Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices is
acceptable)
- Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding.
In any woman of childbearing potential, a pregnancy test must be performed and the
result assessed before trial entry
- Other serious or life-threatening disease before the stroke: severe mental or
physical disability (e.g. Mini Mental Status score <20, or mRS score ≥3), or life
expectancy less than 12 months
- Patient unavailability for follow-up (e.g. no fixed address)
A location was updated in København. New The overall status was updated to "Recruiting" at Bispebjerg hospital. A location was updated in Tartu. New The overall status was updated to "Recruiting" at Tartu University Clinic. A location was updated in Vilnius. New The overall status was updated to "Recruiting" at Vilnius University Hospital. A location was updated in Førde. New The overall status was updated to "Recruiting" at Helse Førde HF. A location was updated in Kristiansand. New The overall status was updated to "Recruiting" at Sørlandet sykehus Kristiansand HF. A location was updated in Levanger. New The overall status was updated to "Recruiting" at Sykehuset Levanger. A location was updated in Sandvika. New The overall status was updated to "Recruiting" at Bærum sykehus Vestre Viken HF. A location was updated in Skien. New The overall status was updated to "Recruiting" at Sykehuset Telemark Skien. A location was updated in Tromsø. New The overall status was updated to "Recruiting" at University Hospital of North Norway, Tromsø. A location was updated in Ålesund. New The overall status was updated to "Recruiting" at Ålesund sjukehus Helse Møre og Romsdal. A location was updated in Malmö. New The overall status was updated to "Recruiting" at Skåne Universitetssjukhus. |
10 Jun '17 |
The description was updated. New
Background:
One in five strokes occur during sleep, but patients with "wake-up" stroke are not given
thrombolytic therapy because time of stroke onset is unknown. On-going trials are testing
alteplase, and use MRI techniques for selection of patients. Tenecteplase has many
pharmacological advantages over alteplase: greater fibrin specificity, very rapid action,
longer half-life, and single bolus administration. In addition, patient selection based on
MRI findings risks excluding many patients that might otherwise benefit. TWIST will test
tenecteplase and will not use MRI techniques for selection of patients. Plain CT and CT
angiography (if possible) will be performed before randomisation, and CT perfusion will be
performed at selected centres, as part of a sub-study.
Study design: TWIST is an international, multi-centre, randomised, open-label,
blinded-endpoint trial of tenecteplase for acute ischaemic 'wake-up' stroke.
Study questions:
1. Can tenecteplase given <4.5 hours of awakening improve functional outcome at 3 months?
2. Can findings on cerebral plain CT and CT angiography (and CT perfusion, at selected
centres) identify patients who benefit from such treatment, compared to other patients?
Patients eligible for treatment who are able to receive tenecteplase within 4.5 hours of
waking, will be randomly allocated to treatment with tenecteplase in addition to best
standard treatment, versus best standard treatment.
Randomisation and treatment: Central randomisation (over the internet) to tenecteplase 0.25
mg/mg i.v. (maximum dose 25 mg) plus best medical treatment vs. best medical treatment
alone.
Imaging: All patients will undergo CT and CT angiography (CTA, if possible) before
randomisation and on day 2. CT perfusion (CTP) will be performed at selected centres, as
part of a sub-study.
Follow-up and primary effect variable: Centralised follow-up via telephone or mail at 3
months. The primary effect variable is functional outcome (modified Rankin Scale score).
Study size and centers: 500 patients from centers in Norway, Sweden, Denmark, Finland,
Estonia, Lithuania, United Kingdom and Switzerland.
Old
Background:
One in five strokes occur during sleep, but patients with "wake-up" stroke are not given
thrombolytic therapy because time of stroke onset is unknown. On-going trials are testing
alteplase, and use MRI techniques for selection of patients. Tenecteplase has many
pharmacological advantages over alteplase: greater fibrin specificity, very rapid action,
longer half-life, and single bolus administration. In addition, patient selection based on
MRI findings risks excluding many patients that might otherwise benefit. TWIST will test
tenecteplase and will not use MRI techniques for selection of patients. Plain CT and CT
angiography (if possible) will be performed before randomisation, and CT perfusion will be
performed at selected centres, as part of a sub-study.
Study design: TWIST is an international, multi-centre, randomised, open-label,
blinded-endpoint trial of tenecteplase for acute ischaemic 'wake-up' stroke.
Study questions:
1. Can tenecteplase given <4.5 hours of awakening improve functional outcome at 3 months?
2. Can findings on cerebral plain CT and CT angiography (and CT perfusion, at selected
centres) identify patients who benefit from such treatment, compared to other patients?
Patients eligible for treatment who are able to receive tenecteplase within 4.5 hours of
waking, will be randomly allocated to treatment with tenecteplase in addition to best
standard treatment, versus best standard treatment.
Randomisation and treatment: Central randomisation (over the internet) to tenecteplase 0.25
mg/mg i.v. (maximum dose 25 mg) plus best medical treatment vs. best medical treatment
alone.
Imaging: All patients will undergo CT and CT angiograpy (CTA, if possible) before
randomisation and on day 2. CT perfusion (CTP) will be performed at selected centres, as
part of a sub-study.
Follow-up and primary effect variable: Centralised follow-up via telephone or mail at 3
months. The primary effect variable is functional outcome (modified Rankin Scale score).
Study size and centers: 500 patients from centers in Norway, Sweden, Denmark, Finland,
Estonia, Lithuania, United Kingdom and Switzerland.
The eligibility criteria were updated. New
Inclusion Criteria:
- Stroke symptoms on awakening that were not present before sleep
- Clinical diagnosis of stroke with limb weakness with NIHSS score >5, or dysphasia
- Treatment with tenecteplase is possible within 4.5 hours of awakening
- Written consent from the patient, non-written consent from the patient (witnessed by
non-participating health care personnel), or written consent from the nearest family
member
Exclusion Criteria:
- Age <18 years
- NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
- Findings on plain CT that indicate that the patient is unlikely to benefit from
treatment:
- Infarction comprising more than >1/3 of the middle cerebral artery territory on
plain CT or CT perfusion
- Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g
cerebral tumour)
- Patient will be treated with intra-arterial interventions for proximal cerebral
artery occlusion
- Active internal bleeding of high risk of bleeding, e.g.:
- Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within
the previous 21 days, or arterial puncture at a non-compressible site within the
previous 7 days
- Any known defect in coagulation, e.g. current use of vitamin K antagonist with
an INR >1.7 or prothrombin time >15 seconds, or use of direct thrombin
inhibitors or direct factor Xa inhibitors during the last 24 hours (unless
reversal of effect can be achieved by agents such as idarucizumab or andexanet)
or with elevated sensitive laboratory tests (such as activated partial
thromboplastin time (aPTT), international normalized ratio (INR), platelet
count, ecarin clotting time, thrombin time (TT), or appropriate factor Xa
activity assays), or heparins during the last 24 hours or with an elevated aPTT
greater than the upper limit of normal
- Known defect of clotting or platelet function or platelet count below
100,000/mm3 (but patients on antiplatelet agents can be included)
- Ischaemic stroke or myocardial infarction in previous 3 months, previous
intracranial haemorrhage, severe traumatic brain injury or intracranial or
intraspinal operation in previous 3 months, or known intracranial neoplasm,
arteriovenous malformation or aneurysm
- Contraindications to tenecteplase, e.g., acute bacterial endocarditis or
pericarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic
failure, cirrhosis, portal hypertension; active hepatitis; systemic cancer with
increased bleeding risk; haemostatic defect including secondary to severe hepatic,
renal disease; organ biopsy; prolonged cardiopulmonary resuscitation > 2 min (within
2 weeks)
- Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg),
despite blood pressure lowering treatment
- Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices is
acceptable)
- Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding.
In any woman of childbearing potential, a pregnancy test must be performed and the
result assessed before trial entry
- Other serious or life-threatening disease before the stroke: severe mental or
physical disability (e.g. Mini Mental Status score <20, or mRS score ≥3), or life
expectancy less than 12 months
- Patient unavailability for follow-up (e.g. no fixed address)
Old
Inclusion Criteria:
- Stroke symptoms on awakening that were not present before sleep
- Clinical diagnosis of stroke with limb weakness with NIHSS score >5, or dysphasia
- Treatment with tenecteplase is possible within 4.5 hours of awakening
- Written consent from the patient, non-written consent from the patient (witnessed by
non-participating health care personnel), or written consent from the nearest family
member
Exclusion Criteria:
- Age <18 years
- NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
- Findings on plain CT that indicate that the patient is unlikely to benefit from
treatment:
- Infarction comprising more than >1/3 of the middle cerebral artery territory on
plain CT or CT perfusion
- Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g
cerebral tumour)
- Patient will be treated with intra-arterial interventions for proximal cerebral
artery occlusion
- Active internal bleeding of high risk of bleeding, e.g.:
- Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within
the previous 21 days, or arterial puncture at a non-compressible site within the
previous 7 days
- Any known defect in coagulation, e.g. current use of vitamin K antagonist with
an INR >1.7 or prothrombin time >15 seconds, or use of direct thrombin
inhibitors or direct factor Xa inhibitors during the last 24 hours (unless
reversal of effect can be achieved by agents such as idarusizumab or andexanet)
or with elevated sensitive laboratory tests (such as aPTT, INR, platelet count,
eucarin clotting time, TT, or appropriate factor Xa activity assays), or
heparins during the last 24 hours or with an elevated aPTT greater than the
upper limit of normal
- Known defect of clotting or platelet function or platelet count below
100,000/mm3 (but patients on antiplatelet agents can be included)
- Ischaemic stroke or myocardial infarction in previous 3 months, previous
intracranial haemorrhage, severe traumatic brain injury or intracranial or
intraspinal operation in previous 3 months, or known intracranial neoplasm,
arteriovenous malformation or aneurysm
- Contraindications to tenecteplase, e.g., acute bacterial endocarditis or
pericarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic
failure, cirrhosis, portal hypertension; active hepatitis; systemic cancer with
increased bleeding risk; haemostatic defect including secondary to severe hepatic,
renal disease; organ biopsy; prolonged cardiopulmonary resuscitation > 2 min (within
2 weeks)
- Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg),
despite blood pressure lowering treatment
- Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices is
acceptable)
- Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding.
In any woman of childbearing potential, a pregnancy test must be performed and the
result assessed before trial entry
- Other serious or life-threatening disease before the stroke: severe mental or
physical disability (e.g. Mini Mental Status score <20, or mRS score ≥3), or life
expectancy less than 12 months
- Patient unavailability for follow-up (e.g. no fixed address)
|
View Trial Locations
Recruitment
- Enrollment: 500
- Gender: All
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: Yes
- 63 locations, 8 countries
Principal Investigators
- Eivind Berge, MD, PhD
Ullevaal University Hospital
- Ellisiv B Mathiesen
University Hospital of North Norway