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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006587
Receipt No. R000007798
Scientific Title Extending the time for Thrombolysis in Emergency Neurological Deficits (International)
Date of disclosure of the study information 2011/10/24
Last modified on 2013/04/26

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Basic information
Public title Extending the time for Thrombolysis in Emergency Neurological Deficits (International)
Acronym EXTEND (International)
Scientific Title Extending the time for Thrombolysis in Emergency Neurological Deficits (International)
Scientific Title:Acronym EXTEND (International)
Region
Japan Asia(except Japan) Australia

Condition
Condition Acute ischemic stroke
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis that ischaemic stroke patients of similar age and stroke severity selected with significant perfusion-diffusion mismatch at 3-9 hours post onset of stroke (based on local legally accepted practice and guideline) will have improved clinical outcomes when given intravenous tPA compared to placebo.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Modified Rankin Scale (mRS) 0-1 at 3 months
Key secondary outcomes Categorical shift in mRS at 3 months.
Change in >= 8 NIHSS points or reaching <= 1 NIHSS points on this scale.
Death due to any cause.
Symptomatic ICH.
Reperfusion at 24 hrs post stroke.
Recanalisation at 24 hrs post stroke.
Infarct growth on DWI within 24 hrs.
Recurrent stroke at 3 months.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 tPA: Tissue Plasminogen Activator (tPA) is given intravenously at the dose of 0.6mg/kg up to a maximum of 60mg, 10% as bolus and the remainder over 1 hour.
Interventions/Control_2 Placebo: Placebo is given intravenously, 10% as bolus and the remainder over 1 hour.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients presenting with acute ischemic stroke.
2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
3. Treatment onset can commence after 3 hours and up to and including 9 hours after stroke onset according to registered product information.
4. Patients who wake with stroke may be included if neurological and other exclusion criteria are satisfied. These wake up strokes are defined as having no symptoms at sleep onset, but stroke symptoms on waking. The time of stroke onset is to be taken as the mid-point between sleep onset (or last known to be normal) and time of waking. The maximum time window for randomisation is then 9 hours from the mid-point as described.
5. NIHSS score of 4 - 26 with clinical signs of hemispheric infarction.
Imaging inclusion criteria.
6. Perfusion-diffusion mismatch: Using a Tmax > 6 second delay, a perfusion volume (PWI) to DWI volume (DWI) ratio of greater than 1.2, and a PWI-DWI difference of greater than 10 ml.
7. A DWI lesion of less than or equal to 70 ml.
Key exclusion criteria 1. Intracranial haemorrhage identified by CT or MRI.
2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of < 4 at randomization.
3. Pre-stroke mRS score of >= 2.
4. Contra indication to imaging with MR with contrast agents.
5. Infarct core >1/3 MCA territory.
6. Participation in any investigational study in the previous 30 days.
7. Any terminal illness such that patient would not be expected to survive more than 1 year.
8. Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
9. Pregnant women.
10. Previous stroke within last three months.
11. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage, arterio-venous malformation, aneurysm, or cerebral neoplasm.
12. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6).
13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
14. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) prior to study entry is permitted.
15. Clinically significant hypoglycaemia.
16. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits.
17. Hereditary or acquired haemorrhagic diathesis.
18. Gastrointestinal or urinary bleeding within the preceding 21 days.
19. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
20. Exposure to a thrombolytic agent within the previous 72 hours.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Geoffrey Donnan
Organization National Stroke Research Institute
Division name Director
Zip code
Address 245 Burgundy Street, Heidelberg, VIC 3084, Australia.
TEL 61-3-9496-2699
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Toyoda, MD, PhD
Organization National Cerebral and Cardiovascular Center
Division name Department of Cerebrovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan.
TEL 06-6833-5012
Homepage URL
Email toyoda@hsp.ncvc.go.jp

Sponsor
Institute National Stroke Research Institute (NSRI)Melbourne Brain Centre
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Australia

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00887328
Org. issuing International ID_1 Clinical trials. gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立循環器病センター 脳血管内科・脳神経内科(大阪府)
中村記念病院 脳神経外科(北海道)
聖マリアンナ医科大学 神経内科(神奈川県)      
熊本大学大学院 生命科学研究部・神経内科(熊本県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In April 2012, the principal investigator concluded that we were not able to participate the EXTEND trial because of a low dose (0.6mg/kg) use of tPA in Japan.
Consequently, we abandoned to start the trial.


Management information
Registered date
2011 Year 10 Month 21 Day
Last modified on
2013 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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