CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 71 enrolled
Drug / intervention
Rivaroxaban +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04569279
NCT04569279Phase 3Completed

Rivaroxaban Compared to Warfarin for Treatment of Cerebral Venous Thrombosis: a Randomized Controlled Trial

Damascus University·interventional·Posted Sep 29, 2020·Updated Feb 16, 2023

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban and Warfarin for Cerebral Vein Thrombosis. Completed, enrolled 71 participants across 1 site.

Detailed Summary

Cerebral venous thrombosis (CVT) is an uncommon venous-type of stroke tends to affect younger patients with somewhat different risk factors and much better outcome compared to arterial strokes. Anti-coagulation is the standard of treatment for patients with (CVT) initially with heparins followed by other oral blood thinners for several months. In this study, the investigators are comparing warfarin with another well-known blood thinner, rivaroxaban, which has a fixed once-daily dose with no need for monitoring in terms of clinical outcomes and complications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSyria
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 29, 2020
Enrollment StartSep 1, 2017
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.8 years ago

Interventions

Rivaroxabandrug

Rivaroxaban (Rovaltro®) is a novel oral anticoagulant that acts selectively, reversibly, and potently on activated Factor X (Factor Xa) inhibiting a critical point on the coagulation cascade. Rivaroxaban has excellent bioavailability, rapid onset of peak anticoagulation effect, and predictable pharmacokinetic and pharmacodynamic properties making routine laboratory monitoring and dose adjustments almost unnecessary (11). Rivaroxaban is an extensively studied drug and has received approvals for anticoagulation in several preventive and therapeutic indications (11). Now medical literature has some solid evidence that Rivaroxaban is comparable with other anticoagulants in terms of efficacy. Several studies imply that Rivaroxaban may have a lower risk of major bleeding (11). Several reports and small case-series (12,13) suggest that rivaroxaban may be beneficial as Warfarin in the treatment of cerebral venous thrombosis (CVT) with less or no major complications.

Warfarindrug

Warfarin (Orfarin®) is the most popular vitamin K antagonist and is considered the standard of care in many venous and arterial anticoagulation indications with extensive clinical experience regarding its use. This inexpensive and effective drug has a narrow therapeutic window that is affected by diet changing and many drug interactions, making frequent monitoring with prothrombin time (PT)/international normalized ratio (INR) highly important.(14)