Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist

Summary

Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH). Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.

Timeline

Start

2016-12

Primary completion

2021-09-30

Completion

2022-03-22

Publications

• Siepen BM, Polymeris A, Shoamanesh A, Connolly S, Steiner T, Poli S, Lemmens R, Goeldlin MB, Muller M, Branca M, Rauch J, Meinel T, Kaesmacher J, Z'Graggen W, Arnold M, Fischer U, Peters N, Engelter ST, Lyrer P, Seiffge D. Andexanet alfa versus non-specific treatments for intracerebral hemorrhage in patients taking factor Xa inhibitors - Individual patient data analysis of ANNEXA-4 and TICH-NOAC. Int J Stroke. 2024 Jun;19(5):506-514. doi: 10.1177/17474930241230209. Epub 2024 Mar 8.
• Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
• Polymeris AA, Karwacki GM, Siepen BM, Schaedelin S, Tsakiris DA, Stippich C, Guzman R, Nickel CH, Sprigg N, Kagi G, Vehoff J, Barinka F, Thilemann S, Maurer M, Wagner B, Traenka C, Gensicke H, De Marchis GM, Bonati LH, Fischer U, Z'Graggen WJ, Nedeltchev K, Wegener S, Baumgartner P, Engelter ST, Seiffge DJ, Peters N, Lyrer PA; TICH-NOAC Investigators. Tranexamic Acid for Intracerebral Hemorrhage in Patients on Non-Vitamin K Antagonist Oral Anticoagulants (TICH-NOAC): A Multicenter, Randomized, Placebo-Controlled, Phase 2 Trial. Stroke. 2023 Sep;54(9):2223-2234. doi: 10.1161/STROKEAHA.123.042866. Epub 2023 Jul 19.

Drugs

Indications