Minor Stroke Therapy Evaluation (MOSTE)
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|ClinicalTrials.gov Identifier: NCT03796468|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : April 27, 2022
Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4.
The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Best Medical Therapy Procedure: Mechanical Thrombectomy||Not Applicable|
Proximal intracranial arterial occlusions cause the most disabling types of ischemic strokes and are predictive of poor neurological outcomes. The "Time is Brain" assessment has been confirmed in many recent trials (MR CLEAN, SWIFT PRIME, REVASCAT, HERMES) within the first 6 hours. Recently the time window has been enlarged to 24h00 after the DAWN trial results, enforcing nevertheless the strong relation between patient disability and time loss in this extended time window.
In population-based studies, patients presenting with minor or mild stroke symptoms represent about two-thirds of stroke patients, and almost one-third of these patients are unable to ambulate independently at the time of discharge.
Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. Indeed, the majority of patients presented with major clinical impairment, with a median NIHSS of 17. Thus, American Heart Association (AHA) gives level 1a evidence for MT performed only for patients with baseline NIHSS score ≥6.
However, patients with proximal occlusions may present with a low NIHSS, a proximal intra-arterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4. In observational study, patient with minor or mild stroke symptoms and LVO have a high risk of both clinical worsening and bad outcome.
The STAIR meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on the available level I evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX consensus recommendations were developed that outline priorities for future research in EVT.
Recent AHA/ASA guidelines have also highlighted the need to gain more evidence to determine whether there is an overall net benefit from endovascular therapy (EVT) in patients with LVO and minor stroke.
The MOSTE protocol is an International, multi-center, prospectively randomized to two parallel (1:1) arms, open to treatment with blinded endpoint trial, designed to demonstrate that mechanical thrombectomy with best medical treatment is superior to medical treatment alone, in improving clinical outcomes at 90 days, in patient presenting an acute large vessel occlusion stroke with a minor deficit, defined as NIHSS below 6 and < 24 hours from onset. If this study is positive, more patients in the future could receive urgent endovascular treatment in addition to the best medical treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||824 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours|
|Actual Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||October 2023|
Best Medical Therapy (BMT)
Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration
Other: Best Medical Therapy
The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies. The rescue MT may be performed in case of deterioration within the 24 hours
Mechanical Thrombectomy (MT)
Endovascular treatment (thrombectomy) associated with the best treatment medical
Procedure: Mechanical Thrombectomy
MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus medical, the MT is performed immediately after the randomization
- Incidence of all-cause mortality at 90 days [ Time Frame: 3 months ]Evaluation of mortality at 90 days
- Incidence of symptomatic intracerebral hemorrhage [ Time Frame: 1 day ]Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization
- Deterioration of patient's condition [ Time Frame: 3 months ]National Intitutes of Health Stroke Scale (NIHSS) ≥ 10 points during hospitalization. this scale is constitued by 15 items and the minimum score is 1 and the maximum score is 20.
- Incidence of procedure/device-related adverse events [ Time Frame: 1 day ]Incidence of procedure/device-related adverse events (in patients treated by mechanical treatment, in the MT group or in the BMT group, in case of rescue therapy)
- Evaluation of functional outcome [ Time Frame: 3 months ]Rate of patients with a favorable or perfect outcome at 90-days defined by mRS 0-2 or mRS 0
- Quality of life of the patient [ Time Frame: 3 months ]Quality of life at 90 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale
- Evaluation of cognitive function [ Time Frame: 3 months ]Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA)
- Evaluation of cognitive function [ Time Frame: 3 months ]Cognitive function at 90-days according to Trail Making Test A and B
- Medico-economic study [ Time Frame: 3 months ]Cost-effectiveness analysis (number of patients functionally independent at 3 months : mRS =< 2), cost of devices and drugs, staff hourly cost, operating room cost
- Evaluation of functional outcome [ Time Frame: 3 months ]Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796468
|Contact: Caroline ARQUIZAN, PH||4 67 33 75 32 ext +firstname.lastname@example.org|
|Contact: Bertrand LAPERGUE, PH||1 46255973 ext +email@example.com|
|Hopital Gui De Chauliac||Recruiting|
|Montpellier, France, 34295|
|Contact: Caroline ARQUIZAN, MD 4 67 33 75 32 ext +33 firstname.lastname@example.org|
|Contact: Vincent COSTALAT, PU-PH 4 67 33 75 32 email@example.com|
|Principal Investigator: Bertrand LAPERGUE, MD|
|Principal Investigator: Tudor JOVIN, MD|
|Principal Investigator:||Vincent COSTALAT, PU-PH||Hôpital Gui de Chauliac|
|Principal Investigator:||Caroline ARQUIZAN, PH||Hôpital Gui de Chauliac|
|Principal Investigator:||Bertrand LAPERGUE, PH||Hôpital Foch|
|Principal Investigator:||Tudor JOVIN, PU-PH||Cooper Neurological Institute|