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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01492725




Registration number
NCT01492725
Ethics application status
Date submitted
20/11/2011
Date registered
15/12/2011
Date last updated
21/04/2015

Titles & IDs
Public title
Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial
Scientific title
A Randomized Controlled Trial of Intra-arterial Reperfusion Therapy After Standard Dose Intravenous t-PA Within 4.5 Hours of Stroke Onset Utilizing Dual Target Imaging Selection.
Secondary ID [1] 0 0
NTA1101
Universal Trial Number (UTN)
Trial acronym
EXTEND-IA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Intra-arterial Clot Retrieval with Solitaire device
Other interventions - intravenous tissue plasminogen activator (tPA)

Experimental: Intra-arterial Clot Retrieval after iv tPA -

Active Comparator: Standard care iv tPA -


Treatment: Devices: Intra-arterial Clot Retrieval with Solitaire device
Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.

Other interventions: intravenous tissue plasminogen activator (tPA)
Standard care IV tPA therapy administered as per registered product information
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reperfusion at 24 hours (CT or MR perfusion imaging)
Timepoint [1] 0 0
24 hours post stroke onset
Primary outcome [2] 0 0
Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS)
Timepoint [2] 0 0
3 days post stroke onset
Secondary outcome [1] 0 0
Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging)
Timepoint [1] 0 0
24 hours post stroke onset
Secondary outcome [2] 0 0
Recanalisation at 24 hrs post stroke (CT or MR angiography)
Timepoint [2] 0 0
24 hours post stroke onset
Secondary outcome [3] 0 0
Infarct growth within 24 hrs (CT and MRI)
Timepoint [3] 0 0
24 hours post stroke onset
Secondary outcome [4] 0 0
Stroke severity (NIHSS) at 24 hours
Timepoint [4] 0 0
24 hours post stroke onset
Secondary outcome [5] 0 0
Symptomatic intra-cranial hemorrhage (ECASS type 2 parenchymal hematoma on CT or MRI combined with >/=4 point deterioration in NIHSS within 36 hours of treatment).
Timepoint [5] 0 0
within 36 hours of intervention
Secondary outcome [6] 0 0
Death due to any cause
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Modified Rankin Scale (mRS) 0-1 at 3 months
Timepoint [7] 0 0
3 months
Secondary outcome [8] 0 0
Categorical shift in mRS at 3 months
Timepoint [8] 0 0
3 months
Secondary outcome [9] 0 0
NIHSS reduction 8 points or reaching 0-1 at 3 months
Timepoint [9] 0 0
3 months
Secondary outcome [10] 0 0
Modified Rankin Scale (mRS) 0-2 at 3 months
Timepoint [10] 0 0
3 months

Eligibility
Key inclusion criteria
1. Patients presenting with anterior circulation acute ischaemic stroke eligible using
standard criteria to receive IV tPA within 4.5 hours of stroke onset

2. Patient, family member or legally responsible person depending on local ethics
requirements has given informed consent

3. Patient"s age is =18 years

4. Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours
of stroke onset.

Imaging inclusion criteria

Dual target:

5. Arterial occlusion on CTA or MRA of the ICA, M1 or M2

6. Mismatch - Using CT or MRI with a Tmax >6 second delay perfusion volume and either
CT-rCBF or DWI infarct core volume. a) Mismatch ratio of greater than 1.2, and b)
Absolute mismatch volume of greater than 10 ml, and. c) Infarct core lesion volume of
less than 70mL
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intracranial haemorrhage (ICH) identified by CT or MRI

2. Rapidly improving symptoms at the discretion of the investigator

3. Pre-stroke mRS score of = 2 (indicating previous disability)

4. Inability to access the cerebral vasculature in the opinion of the neurointerventional
team

5. Contra indication to imaging with MR with contrast agents

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, in the judgment of the investigator 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 (SAH),
arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of
each Investigator.

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. Prior use of
single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) 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. The
definition of "aggressive treatment" is left to the discretion of the responsible
Investigator.

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 hrs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Western Hospital - Melbourne
Recruitment hospital [5] 0 0
Austin Hospital - Melbourne
Recruitment hospital [6] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [7] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2605 - St Leonards
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3011 - Melbourne
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment postcode(s) [7] 0 0
3168 - Melbourne
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients presenting to the emergency department with acute ischaemic stroke, who are eligible
for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for
"dual target" major vessel occlusion and mismatch to determine their eligibility for
randomisation into the trial. If the patient gives informed consent they will be randomised
50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or
IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE)
design.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01492725
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01492725