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NOT YET RECRUITING
NCT07548346
NA

MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis

Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2026-07

Completion Date

2030-01

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

PROCEDURE

Endovascular Thrombectomy

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.

DRUG

Anticoagulation Therapy

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.

Locations (14)

Alexandria University, Smouha Comprehensive Stroke Center

Alexandria, Egypt

Ain Shams University

Cairo, Egypt

Cairo University

Cairo, Egypt

Neurology Department, Al-Azhar University

Cairo, Egypt

Amman Specialized IR Center

Amman, Jordan

Centre Hospitalier Universitaire Ibn Sina de Rabat

Rabat, Morocco

Aga Khan University

Karachi, Pakistan

Weill Cornell Medicine-Qatar

Doha, Qatar

King Khalid University

Abhā, Saudi Arabia

King Abdulaziz Medical City

Jeddah, Saudi Arabia

King Abdullah Medical City

Mecca, Saudi Arabia

Institut National de Neurologie

Tunis, Tunisia

Department of Neurology, Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Neurology Department, Dr. Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)