Ongoing trials evaluating DOACs in the treatment of thrombosis in unusual sites
| Title . | Identifier . | Study design . | Intervention . | Site of thrombosis . | Primary outcome . | No. of patients . | Sponsor . |
|---|---|---|---|---|---|---|---|
| The efficacy and safety of dabigatran etexilate compared with warfarin for the anticoagulation treatment of cerebral venous thrombosis: a pilot study | NCT03217448 | Phase 3 (interventional), randomized, parallel assignment, open label, single (outcomes assessor) | Dabigatran vs warfarin for 6 months | CVT | Recanalization after 6 months | 80 | Capital Medical University, Beijing, China |
| Multicenter, prospective randomized open label, blinded endpoint (PROBE) controlled trial of early anticoagulation with rivaroxaban versus standard of care in determining safety at 365 days in symptomatic cerebral venous thrombosis (SECRET) | NCT03178864 | Interventional, randomized, parallel assignment, single (outcomes assessor) | Rivaroxaban vs standard of care | CVT | Safety of rivaroxaban | 100 | University of British Columbia, Canada |
| Comparing treatment outcomes in CVT patients who were treated with warfarin and rivaroxaban in Isfahan, Iran | NCT03747081 | Interventional, randomized, parallel assignment | Rivaroxaban vs warfarin | CVT | Efficacy of rivaroxaban vs warfarin | 50 | Isfahan University of Medical Sciences, Iran |
| Rivaroxaban compared to warfarin for treatment of cerebral venous thrombosis: a randomized controlled trial | NCT04569279 | Interventional, parallel assignment, open label | Rivaroxaban vs warfarin 6 months | CVT | Change of sinus venous thrombosis severity scale | 71 | Damascus University, Syria |
| Comparison of the efficacy of rivaroxaban to coumadin (warfarin) in cerebral venous thrombosis | NCT03191305 | Interventional, nonrandomized, parallel assignment | Rivaroxaban vs coumadin | CVT | Efficacy of rivaroxaban and comparison to warfarin | 50 | Foundation University Islamabad, Pakistan |
| Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban. A pilot, prospective cohort study | NCT02627053 | Interventional, single group assignment, prospective, cohort study | Rivaroxaban | PVT, MVT, SVT | Safety and efficacy of rivaroxaban at 3 months | 100 | Università degli Studi dell'Insubria, Italy |
| Direct oral anticoagulants for the treatment of cerebral venous thrombosis: an international phase IV study | NCT04660747 | Observational, comparative cohort study, prospective | 3:2 ratio DOAC/VKA | CVT | Composite of major bleeding and symptomatic recurrent venous thrombosis after 6 months | 500 | Academisch Medisch Centrum—Universiteit van Amsterdam (AMC-UvA), The Netherlands |
| International registry on the use of the direct oral anticoagulants for the treatment of unusual site venous thromboembolism | NCT03778502 | Observational, patient registry, prospective, cohort study | Any DOAC | All sites | Evaluate the use of DOACs in unusual-site VTE and to assess safety and effectiveness | 100 | University of Malta, Malta |
| Title . | Identifier . | Study design . | Intervention . | Site of thrombosis . | Primary outcome . | No. of patients . | Sponsor . |
|---|---|---|---|---|---|---|---|
| The efficacy and safety of dabigatran etexilate compared with warfarin for the anticoagulation treatment of cerebral venous thrombosis: a pilot study | NCT03217448 | Phase 3 (interventional), randomized, parallel assignment, open label, single (outcomes assessor) | Dabigatran vs warfarin for 6 months | CVT | Recanalization after 6 months | 80 | Capital Medical University, Beijing, China |
| Multicenter, prospective randomized open label, blinded endpoint (PROBE) controlled trial of early anticoagulation with rivaroxaban versus standard of care in determining safety at 365 days in symptomatic cerebral venous thrombosis (SECRET) | NCT03178864 | Interventional, randomized, parallel assignment, single (outcomes assessor) | Rivaroxaban vs standard of care | CVT | Safety of rivaroxaban | 100 | University of British Columbia, Canada |
| Comparing treatment outcomes in CVT patients who were treated with warfarin and rivaroxaban in Isfahan, Iran | NCT03747081 | Interventional, randomized, parallel assignment | Rivaroxaban vs warfarin | CVT | Efficacy of rivaroxaban vs warfarin | 50 | Isfahan University of Medical Sciences, Iran |
| Rivaroxaban compared to warfarin for treatment of cerebral venous thrombosis: a randomized controlled trial | NCT04569279 | Interventional, parallel assignment, open label | Rivaroxaban vs warfarin 6 months | CVT | Change of sinus venous thrombosis severity scale | 71 | Damascus University, Syria |
| Comparison of the efficacy of rivaroxaban to coumadin (warfarin) in cerebral venous thrombosis | NCT03191305 | Interventional, nonrandomized, parallel assignment | Rivaroxaban vs coumadin | CVT | Efficacy of rivaroxaban and comparison to warfarin | 50 | Foundation University Islamabad, Pakistan |
| Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban. A pilot, prospective cohort study | NCT02627053 | Interventional, single group assignment, prospective, cohort study | Rivaroxaban | PVT, MVT, SVT | Safety and efficacy of rivaroxaban at 3 months | 100 | Università degli Studi dell'Insubria, Italy |
| Direct oral anticoagulants for the treatment of cerebral venous thrombosis: an international phase IV study | NCT04660747 | Observational, comparative cohort study, prospective | 3:2 ratio DOAC/VKA | CVT | Composite of major bleeding and symptomatic recurrent venous thrombosis after 6 months | 500 | Academisch Medisch Centrum—Universiteit van Amsterdam (AMC-UvA), The Netherlands |
| International registry on the use of the direct oral anticoagulants for the treatment of unusual site venous thromboembolism | NCT03778502 | Observational, patient registry, prospective, cohort study | Any DOAC | All sites | Evaluate the use of DOACs in unusual-site VTE and to assess safety and effectiveness | 100 | University of Malta, Malta |