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EXTEND-IA: Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial

Sponsor
Neuroscience Trials Australia (Other)
Overall Status
Terminated
CT.gov ID
NCT01492725
Collaborator
(none)
70
Enrollment
9
Locations
2
Arms
30
Duration (Months)
7.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intra-arterial Clot Retrieval with Solitaire device
  • Genetic: intravenous tissue plasminogen activator (tPA)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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.
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intra-arterial Clot Retrieval after iv tPA

Device: 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.
Active Comparator: Standard care iv tPA

Genetic: intravenous tissue plasminogen activator (tPA)
Standard care IV tPA therapy administered as per registered product information

Outcome Measures

Primary Outcome Measures

  1. Reperfusion at 24 hours (CT or MR perfusion imaging) [24 hours post stroke onset]

  2. Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) [3 days post stroke onset]

    NIHSS - reduction >/= 8 points or reaching 0-1)

Secondary Outcome Measures

  1. Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging) [24 hours post stroke onset]

  2. Recanalisation at 24 hrs post stroke (CT or MR angiography) [24 hours post stroke onset]

  3. Infarct growth within 24 hrs (CT and MRI) [24 hours post stroke onset]

  4. Stroke severity (NIHSS) at 24 hours [24 hours post stroke onset]

  5. 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). [within 36 hours of intervention]

  6. Death due to any cause [3 months]

  7. Modified Rankin Scale (mRS) 0-1 at 3 months [3 months]

  8. Categorical shift in mRS at 3 months [3 months]

  9. NIHSS reduction 8 points or reaching 0-1 at 3 months [3 months]

  10. Modified Rankin Scale (mRS) 0-2 at 3 months [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

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

  2. 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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 John Hunter Hospital New Lambton Heights New South Wales Australia 2305
2 Royal North Shore Hospital St Leonards New South Wales Australia 2605
3 Royal Adelaide Hospital Adelaide South Australia Australia 5000
4 Western Hospital Melbourne Victoria Australia 3011
5 Austin Hospital Melbourne Victoria Australia 3084
6 Box Hill Hospital Melbourne Victoria Australia 3128
7 Monash Medical Centre Melbourne Victoria Australia 3168
8 Royal Melbourne Hospital Melbourne Victoria Australia
9 Auckland Hospital Grafton Auckland New Zealand 1001

Sponsors and Collaborators

  • Neuroscience Trials Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neuroscience Trials Australia
ClinicalTrials.gov Identifier:
NCT01492725
Other Study ID Numbers:
  • NTA1101
First Posted:
Dec 15, 2011
Last Update Posted:
Apr 21, 2015
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Ischemic Stroke
Plasminogen
Tissue Plasminogen Activator

Study Results

No Results Posted as of Apr 21, 2015