Clinical Trials Logo

Clinical Trial Summary

The study will be a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5 hours of stroke onset. Randomised patients will be stratified for site of baseline arterial occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot retrieval.


Clinical Trial Description

The DIRECT-SAFE trial will include patients with acute ischemic stroke, who are ≥18 years of age and are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset. Patients will be assessed for large vessel occlusion to determine their eligibility for randomization into the trial. Eligible vessel occlusions include the internal carotid artery, basilar artery or middle cerebral artery (M1 or M2). Patients will be consented after large vessel occlusion is confirmed based on standard care multimodal imaging.

Patients will be recruited in Australia and New Zealand, China, Taiwan and Europe. Randomisation either direct to ECR or standard thrombolytic therapy and ECR shall be in a 1:1 ratio.

All patients will have a multimodal MR (or CT/CTP at investigator's discretion if MRI not possible) at 18 to 30 hours post treatment to assess reperfusion, recanalization, ischemic core growth and hemorrhagic transformation. Final follow up will occur at Day 90. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03494920
Study type Interventional
Source Neuroscience Trials Australia
Contact Bernard Yan, MD
Phone 039349 2477
Email bernard.yan@mh.org.au
Status Recruiting
Phase Phase 3
Start date April 27, 2018
Completion date May 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT03728738 - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke Phase 3
Recruiting NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders N/A
Recruiting NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2
Suspended NCT01852201 - POSITIVE Stroke Clinical Trial N/A
Completed NCT02924168 - Radial Shock Waves for Functional Disability in Stroke N/A
Not yet recruiting NCT01923818 - Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events Phase 2/Phase 3
Completed NCT01968122 - Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China N/A
Completed NCT01983644 - RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study N/A
Completed NCT02184936 - Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke N/A
Completed NCT01949948 - Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke Phase 3
Recruiting NCT01526824 - Lovaza's Effect on Clopidogrel in a Neuro Population Phase 0
Completed NCT01188824 - The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study) Phase 4