MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis

NCT07548346 | Not Yet Recruiting DMC

• 1 other identifier: MENASINO-REVIVE-2026-01
• Study Type: interventional
• Target: 440
• Locations: 7 countries
• Sites: 13

Brief 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). 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.

Conditions

Cerebral Venous Sinus Thrombosis

Keywords

CVST; endovascular thrombectomy; anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after randomization

Secondary Outcomes (7)

• Venous sinus recanalization rate at Day 7

  7 days after randomization

• Modified Rankin Scale (mRS) ordinal shift analysis

  6 and 12 months after randomization

• All-cause mortality

  30 days and 12 months after randomization

• Time to clinical improvement

  Up to 12 months after randomization

• Health-related quality of life (EQ-5D-5L)

  6 and 12 months after randomization

Other Outcomes (1)

• Safety composite: sICH and major procedural complications (co-primary safety endpoint)

  72 hours (sICH) and 30 days (procedural complications) after randomization

Study Arms (2)

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.

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.

Drug: Anticoagulation Therapy

Interventions

Endovascular Thrombectomy PROCEDURE

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.

Endovascular Thrombectomy Plus Anticoagulation

Anticoagulation Therapy DRUG

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.

Anticoagulation Alone; Endovascular Thrombectomy Plus Anticoagulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Middle East North Africa Stroke and Interventional Neurotherapies Organization: lead

Study Sites (14)

Alexandria University, Smouha Comprehensive Stroke Center

Alexandria, Egypt

Location

Ain Shams University

Cairo, Egypt

Location

Cairo University

Cairo, Egypt

Location

Neurology Department, Al-Azhar University

Cairo, Egypt

Location

Amman Specialized IR Center

Amman, Jordan

Location

Centre Hospitalier Universitaire Ibn Sina de Rabat

Rabat, Morocco

Location

Aga Khan University

Karachi, Pakistan

Location

Weill Cornell Medicine-Qatar

Doha, Qatar

Location

King Khalid University

Abhā, Saudi Arabia

Location

King Abdulaziz Medical City

Jeddah, Saudi Arabia

Location

King Abdullah Medical City

Mecca, Saudi Arabia

Location

Institut National de Neurologie

Tunis, Tunisia

Location

Department of Neurology, Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

Neurology Department, Dr. Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anticoagulation Bridge

Intervention Hierarchy (Ancestors)

Bridge Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Alexandria University

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

JO (1); TU (2); SA (3); MO (1); EG (4); QA (1); PA (1)