REVIVE-CVST is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial evaluating whether early endovascular thrombectomy (EVT) combined with standard anticoagulation improves outcomes compared to anticoagulation alone in patients with severe cerebral venous sinus thrombosis (CVST).
The study targets adult patients (aged 18 years or older) presenting within 14 days of symptom onset with imaging-confirmed CVST and at least one severity marker, such as a Glasgow Coma Scale score of 14 or below, intracerebral hemorrhage, venous infarction, or deep venous system involvement.
Participants will be randomly assigned in a 1:1 ratio to either the intervention arm (EVT plus anticoagulation) or the control arm (anticoagulation alone). The primary endpoint is functional outcome at 180 days as measured by the modified Rankin Scale (mRS), using a shift analysis across all mRS categories.
The trial aims to enroll 440 participants across approximately 15 centers in the Middle East, North Africa, South Asia, and Turkey (MENA-SINO network). The study duration is approximately 42 months, including 18 months of enrollment and 12 months of follow-up for the last enrolled patient.
Age 18-65 years, inclusive
Radiologically confirmed cerebral venous sinus thrombosis (CVST) by CT venography (CTV), MR venography (MRV), or digital subtraction angiography (DSA), with thrombosis of at least one major dural sinus
Acute or subacute presentation with symptom onset within 21 days of randomization
MRI phase characterization confirming acute or subacute phase
Isolated cortical vein thrombosis without dural sinus involvement
Isolated cavernous sinus thrombosis
Chronic-phase CVST on MRI phase characterization
Pre-morbid modified Rankin Scale (mRS) score greater than 2
Parallel
Endovascular Thrombectomy
Procedure/SurgeryEndovascular thrombectomy (EVT) performed within 24 hours of randomization. Techniques include mechanical thrombectomy using stent retrievers, aspiration thrombectomy, balloon-assisted thrombectomy, or a combination approach at the discretion of the treating neurointerventionalist. The procedure is performed under general anesthesia or conscious sedation via femoral venous access with navigation to the affected cerebral venous sinus.
Anticoagulation Therapy
DrugStandard anticoagulation therapy consisting of intravenous unfractionated heparin (UFH) or subcutaneous low-molecular-weight heparin (LMWH) during the acute phase, followed by oral anticoagulation with warfarin (target INR 2.0-3.0) or direct oral anticoagulants (DOACs) for 3-12 months as per current AHA/ASA and ESO guidelines. Both arms receive this intervention.
Proportion of patients achieving functional independence (mRS 0-2) at 12 months
The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 12 months after randomization, assessed by a blinded central adjudication committee. The mRS is a 7-point disability scale ranging from 0 (no symptoms) to 6 (death). A score of 0-2 indicates functional independence.
Venous sinus recanalization rate at Day 7
Proportion of patients achieving partial or complete recanalization of the affected venous sinuses at Day 7, assessed by CT venography (CTV) or MR venography (MRV). Recanalization is graded as no recanalization, partial recanalization, or complete recanalization by a blinded central imaging core lab.
Modified Rankin Scale (mRS) ordinal shift analysis
Ordinal shift analysis of the full modified Rankin Scale (mRS) distribution at 6 and 12 months, comparing the distribution of scores between the two treatment arms using ordinal logistic regression. The mRS ranges from 0 (no symptoms) to 6 (death).
All-cause mortality
All-cause mortality at 30 days and 12 months after randomization.
Time to clinical improvement
Time from randomization to clinical improvement, defined as a reduction of 2 or more points on the National Institutes of Health Stroke Scale (NIHSS) or discharge from hospital, whichever occurs first.
Safety composite: sICH and major procedural complications (co-primary safety endpoint)
Co-primary safety endpoint comprising: (1) symptomatic intracranial hemorrhage (sICH) within 72 hours, defined as new or worsening hemorrhage on imaging with clinical deterioration (increase of 4 or more points on NIHSS); and (2) major procedural complications within 30 days, including vessel perforation, dissection, or device-related events requiring intervention.
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Middle East North Africa Stroke and Interventional Neurotherapies Organization
Lead sponsor
Alexandria University
Sponsor institution
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