Cerebral Venous Sinus ThrombosisREVIVE-CVSTNCT07548346
MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis
A study testing Endovascular Thrombectomy and Anticoagulation Therapy in people with Cerebral Venous Sinus Thrombosis, run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 14 sites in 8 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Venous Sinus Thrombosis
- What is being tested?
- Endovascular Thrombectomy and Anticoagulation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 1 Jan 2025to Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
14 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 8 countries
Egypt4 sites, 4 recruiting
- Recruiting
Alexandria University, Smouha Comprehensive Stroke Center
Alexandria
Ossama Mansour, MD, PhD, +20-3-4282929, ossama.mansour@alexmed.edu.eg
- Recruiting
Ain Shams University
Cairo
Amr Mahmoud, MD, +20 11 19899341, amr.radiology@gmail.com
- Recruiting
Cairo University
Cairo
Farouk Hassan, MD, +20 100 535 8346, faroukkeden@yahoo.com
- Recruiting
Neurology Department, Al-Azhar University
Cairo
Khaled Sobh, MD, +20 106 988 1813, khaledsobh@yahoo.com
Saudi Arabia3 sites, 3 recruiting
- Recruiting
King Khalid University
Abhā
Ibrahin Alnaami, MD, +966 59 901 0501, ialnaami@gmail.com
- Not yet recruiting
King Abdulaziz Medical City
Jeddah
- Recruiting
King Abdullah Medical City
Mecca
Faisal Alghamdi, MD, +966 54 122 4152, faisal.gh.30@gmail.com
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Department of Neurology, Eskisehir Osmangazi University
Eskişehir
Atilla Ozcan Ozdemir, MD, +90 532 617 22 11, atillaozcanozdemir@gmail.com
- Recruiting
Neurology Department, Dr. Lutfi Kirdar City Hospital
Istanbul
Erdem Gurkas, MD, +90 505 240 3987, erdemgurkas@yahoo.com
Morocco1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Ibn Sina de Rabat
Rabat
Tunisia1 site, 1 recruiting
- Not yet recruiting
Institut National de Neurologie
Tunis
About this study
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
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.
Read more
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.
Read the detailed description
BACKGROUND: Cerebral venous sinus thrombosis (CVST) accounts for approximately 0.5-1% of all strokes and disproportionately affects younger patients, particularly women. While anticoagulation remains the standard of care, approximately 15% of patients experience poor outcomes despite treatment. Endovascular thrombectomy (EVT) has emerged as a potential adjunctive therapy for severe CVST, but high-quality evidence from randomized controlled trials is lacking, particularly from the Middle East, North Africa, and South Asia regions where CVST prevalence may be higher.
STUDY DESIGN: This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Participants are randomized 1:1 to either EVT plus anticoagulation (intervention) or anticoagulation alone (control). Randomization is stratified by site and presence of intracerebral hemorrhage.
INTERVENTION ARM: Patients receive endovascular thrombectomy using mechanical thrombectomy devices, aspiration catheters, or balloon-assisted techniques, performed within 24 hours of randomization. All patients also receive standard anticoagulation therapy.
CONTROL ARM: Patients receive standard anticoagulation therapy alone, consisting of intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin, followed by oral anticoagulation for 3-12 months per guidelines.
FOLLOW-UP: Assessments are conducted at 30 days, 90 days, and 180 days post-randomization. The primary endpoint assessment occurs at 180 days. Follow-up includes clinical assessments (mRS, NIHSS), quality of life measures (EQ-5D-5L), and imaging at 90 days.
STATISTICAL ANALYSIS: The primary analysis uses ordinal logistic regression (shift analysis) of the mRS at 180 days. The study is powered at 80% to detect a common odds ratio of 1.5 with a two-sided alpha of 0.05, requiring 440 participants (220 per arm) including a 10% attrition allowance.
SAFETY: An independent Data Safety Monitoring Board (DSMB) will conduct interim analyses after enrollment of 25%, 50%, and 75% of participants. Pre-specified stopping rules are based on the Haybittle-Peto boundary.
- Conditions
- Cerebral Venous Sinus Thrombosis
- Being tested
- Endovascular Thrombectomy, Anticoagulation Therapy
- Keywords
- CVST, endovascular thrombectomy, anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ThrombectomyProcedure or surgery
Endovascular 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 TherapyDrug
Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Thrombectomy Plus Anticoagulation | Experimental | Participants in this arm will receive endovascular thrombectomy (EVT) within 24 hours of randomization, in addition to standard anticoagulation therapy. EVT techniques may include mechanical thrombectomy, aspiration thrombectomy, or balloon-assisted techniques at the discretion of the treating interventionalist. Standard anticoagulation consists of intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin, followed by oral anticoagulation for 3-12 months per guidelines. Receives: Procedure: Endovascular Thrombectomy; Drug: Anticoagulation Therapy |
| Anticoagulation Alone | Active comparator | Participants in this arm will receive standard anticoagulation therapy alone. Treatment consists of intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin during the acute phase, followed by oral anticoagulation (warfarin or direct oral anticoagulants) for 3-12 months as per current guidelines. No endovascular intervention will be performed. Receives: Drug: Anticoagulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after randomization
Secondary outcomes (7)
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.
Measured: 7 days after randomization
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).
Measured: 6 and 12 months after randomization
All-cause mortality
All-cause mortality at 30 days and 12 months after randomization.
Measured: 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.
Measured: Up to 12 months after randomization
Health-related quality of life (EQ-5D-5L)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument at 6 and 12 months after randomization. The EQ-5D-5L measures health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 6 and 12 months after randomization
Cognitive function (Montreal Cognitive Assessment)
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) at 6 and 12 months after randomization. The MoCA is a 30-point screening tool for mild cognitive dysfunction, with scores ranging from 0 to 30. Higher scores indicate better cognitive function; a score of 26 or above is considered normal.
Measured: 6 and 12 months after randomization
Seizure frequency
Frequency and type of seizures (focal or generalized) occurring during the follow-up period, documented at each study visit.
Measured: Up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Jan 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous Sinus ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ossama Mansour, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548346
- Sponsor's protocol ID
- MENASINO-REVIVE-2026-01
- Acronym
- REVIVE-CVST
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided