AFFINITY: Assessment of fluoxetine in stroke recovery trial
Lead PI: Graeme J Hankey and Maree L. Hackett
No. of Patients Currently Recruited: 246 No. of Patients Required: 1600
An Australian-lead investigator initiated, multi-centre, prospective, randomized, parallel group, double blind placebo-controlled trial to establish the effect(s) of routine administration of fluoxetine (20mg once daily) for 6 months in patients with recent stroke on functional outcome at 6 months and one year.
ANZCTR No: ACTRN12611000774921
CHARM: Cirara in large Hemispheric infarction Analysing mRS and Mortality
Lead PI: Dr Bruce Campbell
Status: ASTN endorsed
No. of Patients Currently Recruited: 0 No. of Patients Required: tbc
Edema in larger hemispheric infarction can cause neurological deterioration and death. Intravenous glyburide acts on SUR-1 receptors to reduce edema after ischemic stroke. The hypothesis of the CHARM phase 3 randomised trial is that intravenous glyburide will improve the functional outcome after large hemispheric stroke compared to placebo.
COMPARE: Participant Information for People With Aphasia Constraint Induced or Multi-Modal aphasia rehabilitation: A Randomised Controlled Trial (RCT) for stroke related chronic aphasia
Lead PI: Associate Professor Miranda Rose
No. of Patients Currently Recruited: 1 No. of Patients Required: 216
COMPARE is a randomized controlled trial of 216 participants comparing Constraint Induced Aphasia Therapy and Multi-modality Aphasia Therapy to usual care for people with aphasia 6 months to 15 years following stroke. Primary outcome is aphasia severity immediately following treatment plus secondary outcomes at 3 months post treatment. An economic analysis will occur.
ANZCTR No: ACTRN126125000618550
EXTEND-IA TNK: Extending the time for thrombolysis in emergency neurological deficits - intra-arterial with tenecteplase
Lead PI: Dr Bruce Campbell
Status: Recruiting / Site Selection
No. of Patients Currently Recruited: 53 No. of Patients Required: tbc
Rapid reperfusion is the key to improved ischemic stroke outcomes. Tenecteplase may be safer and more effective than alteplase. The hypothesis of the EXTEND-IA TNK randomised trial is that intravenous tenecteplase will achieve reperfusion prior to cerebral angiography more frequently than intravenous alteplase in patients eligible for clot retrieval.
INSPIRE: INternational Stroke Perfusion Imaging REgistry
Lead PI: John Hunter Hospital
No. of Patients Currently Recruited: 1500 No. of Patients Required: 2000
INSPIRE is an international web-based database collecting imaging and clinical stroke data to measure implementation of advanced CT image in stroke, So far, INSPIRE has recruited around 1500 patients from sitesacross Australi, China Canada and India. The fist stage of data analysis has been completed, leading to 4 research papers (3 ongoing and 1 published).
VERSE: Very Early Rehabilitation in Speech after Stroke
Lead PI: Associate Professor Erin Godecke
No. of Patients Currently Recruited: 123 No. of Patients Required: 246
This 3-arm randomised controlled trial (RCT) aims to determine whether a standardised, intensive aphasia therapy regimen (VERSE) is more effective and cost saving than intensive non-standardised usual care training (UC-Plus) and regular usual care (US) therapy provided at 12 weeks post stroke.
ANZCTR No: ACTRN12613000776707
EXTEND: Extending the time for Thrombolysis in Emergency Neurological Deficits
Phase III, randomised, multicentre, double blinded, placebo controlled trial (2 arm with 1:1 randomisation) within a larger cohort study of ischaemic stroke patients. Patients randomised to treatment will be stratified for time of randomisation after stroke to within <6 hours and 6-9 hours. The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.
A total of 400 participants shall be recruited.
Extend Investigators in China
INSPIRE: INternational Stroke Perfusion Imaging Registry
The primary objective of INSPIRE will be to use an interationally unique web-based database of imaging and clinical stroke data to validate the use of CTP to predict imaging and clinical outcomes, including the use of CTP to refine the selection of patients for thrombolysis. A total of 20 sites across Australia, New Zealand and China will be involved in the study. INSPIRE is headed by A/Prof Mark Parsons with other members including: Prof Chris Levi, Prof John Attia, Prof Stephen Davis, Prof Geoff Donnan, Dr Qing Yang and A/Prof Bernard Yan.
INSPIRE is the first study to be undertaken under the newly established ASTN CHINA office.
CIRCIT: Circit class therapy for Increasing Rehabilitation Intensity of Therapy trial
CIRCIT is a multi-centre randomized controlled trial with assessor blinding. It is a 3-armed trial which aims to examine the effectiveness of two distinct models of increasing the dose of physiotherapy provided to people during sub-acute rehabilitation. Usual care physiotherapy (provided over 5 day week) is the control group and will be compared to usual care therapy provided over 7 days a week (7-day therapy) and group circuit therapy provided over 5-days a week (circuit class therapy). The group nature of circuit class therapy has been proven able to deliver an approximate four-fold increase in therapy dose per working day. The primary outcome is walking capacity (6 minute walk test) at 4 weeks. The secondary aim is to examine the relative cost-effectiveness of the dofferent models of care.
We are currently recruiting from three rehabilitation centres in South Australia, one in Western Australia amd a fifth site in Victoria soon to commence recruitment. Our target sample is 282.
AVERT: A Very Early Rehabilitation Trial
AVERT is a Phase III, international, multicentre, single blind trial comparing earlier onset and higher dose rehabilitation (mobility emphasis) with standard care. This is an investigator driven trial with NHMRC grant support. Primary outcome is death/disability at 3 months. A cost effectiveness sub-study runs beside the trial. Inclusion criteria are broad: patients > 18 years (no upper age limit), admitted <24 hours of ischemic and haemorrhagic stroke to a stroke unit. Those treated with rtPA are also eligible. Intervention is provided by a nurse/physiotherapist team.
A total of 2104 patients will be recruited to this trial.
AVERT Investigators Australia
Insulin Resistance Intervention After Stroke Trial
Phase III, randomized, double-blind, placebo controlled trial. The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke. The IRIS trial will test a new treatment strategy based on evidence linking insulin resistance to increased risk for stroke and other vascular diseases. Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effects. This condition can lead to diabetes and is thought to cause blood vessel disease, including stroke and heart attack, in patients with and without diabetes.
A total of 3136 participants shall be recruited.
Intra-arterial Plasmin Study
A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke.
Phase 1/2a, open-label, multi-center, sequential dose escalation, safety study of Plasmin (Human) in acute ischemic stroke caused by middle cerebral artery occlusion documented by arteriography. Plasmin (Human) will be administered through a catheter into the thrombus within 9 hours of stroke onset. A maximum of seventy-five (75) patients will receive Plasmin (Human), a maximum of twenty-five (25) patients at each of the 3 dose levels (20 mg, 40 mg, and 60 mg). The objectives of this study are to determine the safety and tolerability of Plasmin (Human), to select a dose for further testing, and to determine the proportion of patients with partial or full recanalization.
A total of 75 participants shall be recruited.
IMS III: Interventional Management of Stroke Trial
Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone When Initiated Within Three Hours of Acute Ischemic Stroke Onset. IV rt-PA is an effective therapy for acute ischemic stroke but has substantial limitations when used alone to open blocked arteries The Interventional Management of Stroke (IMS III) Trial is a multi-center study that will compare two different treatment approaches for restoring blood flow to the brain. One approach, giving the clot-dissolving drug rt-PA, is already FDA-approved when given through a vein (IV). This treatment will be compared to a new approach, giving rt-PA at a lower dose first through IV in the arm and then, if a blood clot in the brain artery is found, through a small tube or catheter at the site of the blood clot (intra-arterial or IA) to see which is better. Both approaches must be initiated within three hours of stroke onset.
A total of 900 participants shall be recruited