EXTEND-IA: Extending the time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial, a randomised trial of clot retrieval after intravenous thrombolysis in ischemic stroke

Phase 2

• Conditions: Ischemic stroke; Stroke - Ischaemic

• Registration Number: ACTRN12611000969965
• Lead Sponsor: Florey Institute of Neuroscience and Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 100

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 70m

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 (clinically evident)
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. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or 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. 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 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reperfusion at 24 hours (CT or MR perfusion imaging)[24 hours post stroke onset];Favourable clinical response (National Institutes of Health Stroke Score - NIHSS - reduction >/= 8 points or reaching 0-1) at 3 days[3 days post stroke onset]

Secondary Outcome Measures

Name	Time	Method
Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging)[24 hours post stroke onset];Recanalisation at 24 hrs post stroke (CT or MR angiography)[24 hours post stroke onset];Infarct growth within 24 hrs (CT and MRI)[24 hours post stroke onset];Stroke severity (NIHSS) at 24 hours[24 hours post stroke onset];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];Death due to any cause[3 months];Modified Rankin Scale (mRS) 0-1 at 3 months[3 months];Categorical shift in mRS at 3 months[3 months];NIHSS reduction 8 points or reaching 0-1 at 3 months[3 months];Modified Rankin Scale (mRS) 0-2 at 3 months[3 months]