Endovascular treatment plus anticoagulation for severe CVST in the MENA region
Official title: REVIVE-CVST: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint (PROBE) Trial of Endovascular Thrombectomy Plus Standard Medical Care Versus Standard Medical Care Alone in Adults With Acute or Subacute Cerebral Venous Sinus Thrombosis at High Risk of Poor Outcome in the Middle East and North Africa Region
Run by Middle East North Africa Stroke and Interventional Neurotherapies Organization · NCT07548346 · Data updated 2026-11-12
This trial tests whether adding endovascular thrombectomy to standard anticoagulation helps adults with severe cerebral venous sinus thrombosis see better outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 440 (estimated) |
| Sponsor | Middle East North Africa Stroke and Interventional Neurotherapies Organization Academic / other |
| Locations | 14 sites (Alexandria and 13 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 2029 |
| Study ends | January 2030 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07548346 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with imaging-confirmed CVST and at least one severity marker who present within 21 days and can consent or have a legally authorized representative.
✕Probably not a fit
Patients without a response to EVT, with contraindications to thrombectomy or anticoagulation, or with conditions that preclude participation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
REVIVE-CVST is a multicenter, randomized trial comparing endovascular thrombectomy plus anticoagulation versus anticoagulation alone in adults with severe CVST. Participants are enrolled within 21 days of symptom onset and randomized 1:1, stratified by site and intracerebral hemorrhage status. The intervention uses mechanical thrombectomy, aspiration, or balloon-assisted approaches within 24 hours of randomization, in addition to standard anticoagulation. Follow-up visits occur at 30, 90, and 180 days, with the primary endpoint assessed at 180 days using the modified Rankin Scale across its full range. The study aims to enroll about 440 participants at roughly 15 centers in the MENA region.
Why it matters
Potential benefit: If successful, patients with severe CVST could have improved functional recovery and independence at 180 days.
How similar studies have gone: High-quality randomized data in CVST are limited; this trial builds on emerging evidence suggesting potential benefit of EVT in severe cases, but results are needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * At least one risk factor for poor outcome: symptoms of intracranial hypertension (severe headache, papilledema, visual obscurations), focal neurological deficit, seizures, altered consciousness (GCS 9-14), intracranial hemorrhage from venous congestion, or deep venous system thrombosis * Significant venous outflow obstruction on imaging * Written informed consent from patient or legally authorized representative Exclusion Criteria: * 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 * Glasgow Coma Scale (GCS) score less than 9 at randomization * Imminent risk of transtentorial herniation requiring emergent decompressive craniectomy * Massive cerebral edema with midline shift greater than 10 mm requiring surgical intervention * Active systemic bleeding or hemorrhagic diathesis * Severe allergy to iodinated contrast media * CVST secondary to active hematological malignancy or life expectancy less than 12 months * Pregnancy * Participation in another interventional clinical trial within 30 days * Any condition rendering the patient unsuitable for study participation per investigator judgment
Where it's running
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Alexandria University, Smouha Comprehensive Stroke Center
Alexandria, Egypt Recruiting -
Ain Shams University
Cairo, Egypt Recruiting -
Cairo University
Cairo, Egypt Recruiting -
Neurology Department, Al-Azhar University
Cairo, Egypt Recruiting -
King Khalid University
Abhā, Saudi Arabia Recruiting -
King Abdullah Medical City
Mecca, Saudi Arabia Recruiting
Show 8 more locations
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Department of Neurology, Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye) Recruiting -
Neurology Department, Dr. Lutfi Kirdar City Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Amman Specialized IR Center
Amman, Jordan Not yet recruiting -
Centre Hospitalier Universitaire Ibn Sina de Rabat
Rabat, Morocco Not yet recruiting -
Aga Khan University
Karachi, Pakistan Not yet recruiting -
Weill Cornell Medicine-Qatar
Doha, Qatar Not yet recruiting -
King Abdulaziz Medical City
Jeddah, Saudi Arabia Not yet recruiting -
Institut National de Neurologie
Tunis, Tunisia Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Danang Cerebral Venous Thrombosis Registry
This registry collects information on adults with cerebral venous thrombosis admitted to Danang Hospital to see how the condition presents, what imaging shows, risk factors, and how patients recover.
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Investigating cerebral vein thrombosis in Norway
This study looks at how common cerebral vein thrombosis is in Norway, what causes it, how it's treated, and what happens to patients in the long run.
-
Cerebral Venous Thrombosis Cohort: Features and Treatments in China
This study follows people with cerebral venous thrombosis in China to see how the condition presents, progresses, and responds to current treatments, while collecting blood and spinal fluid to explore biomarkers.
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Anticoagulation Plus Tocilizumab for Acute Cerebral Venous Thrombosis
This study tests whether adding a single dose of tocilizumab to standard blood thinners helps people with acute cerebral venous thrombosis.
-
Anticoagulation plus batroxobin for acute cerebral venous thrombosis
This trial tests whether adding batroxobin to standard anticoagulation helps adults with acute cerebral venous thrombosis.
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DOAC treatment outcomes for cerebral venous thrombosis in Vietnam
This project will try direct oral anticoagulants (dabigatran or rivaroxaban) in adults with cerebral venous thrombosis to see if they are safe and effective in routine care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.