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IMS III: Interventional Management of Stroke Trial

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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
Last Updated ( Tuesday, 25 August 2015 13:13 )
 

Intra-arterial Plasmin Study

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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. 

 

Last Updated ( Tuesday, 25 August 2015 13:14 )
 

Insulin Resistance Intervention After Stroke Trial

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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. 

Last Updated ( Tuesday, 25 August 2015 13:14 )
 

AVERT: A Very Early Rehabilitation Trial

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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

Last Updated ( Wednesday, 10 January 2018 12:50 )
 
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