drugset / Trial / NCT03496883
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
Phase 3
Active not recruiting
860 enrolled
Joseph Broderick, MD
National Institute of Neurological Disorders and Stroke (NINDS) · collabNovo Nordisk A/S · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.
Timeline
- Start
- 2021-12-03
- Primary completion
- 2028-01-01
- Completion
- 2028-01-01
Publications
- Broderick JP, Naidech AM, Elm JJ, Toyoda K, Dowlatshahi D, Demchuk AM, Khatri P, Steiner T, Bath PM, Audebert HJ, Vagal A, Yoshimura S, Mayer SA, Wang LL, Sabagha N, Mocco JD, Molina C, Aviv R, Stinson E, Quadri SA, Carrozzella J, Huynh T, Phan A, Beall J, Davis I, Sakai N, Ohta T, Yokosawa M, Hara T, Sangha N, Morita K, Dominc Tse MY, Streib CD, Miyashita F, Silva Y, Nagakane Y, Gheorghiu T, Sun CH, Hirano T, Poli S, Izumo T, Fukuda-Doi M, Ihara M, Koga M, Buck B, Walsh KB, Spokovny I, Grotta JC; FASTEST Investigators. Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Feb 21;407(10530):773-783. doi: 10.1016/S0140-6736(26)00097-8. Epub 2026 Feb 4.
- Yu W, Alexander MJ. Spontaneous intracerebral hemorrhage: Recent advances and critical thinking on future clinical trial design. Chin Med J (Engl). 2024 Dec 20;137(24):2899-2906. doi: 10.1097/CM9.0000000000003408. Epub 2024 Dec 10. No abstract available.
- 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.
- Naidech AM, Grotta J, Elm J, Janis S, Dowlatshahi D, Toyoda K, Steiner T, Mayer SA, Khanolkar P, Denlinger J, Audebert HJ, Molina C, Khatri P, Sprigg N, Vagal A, Broderick JP. Recombinant factor VIIa for hemorrhagic stroke treatment at earliest possible time (FASTEST): Protocol for a phase III, double-blind, randomized, placebo-controlled trial. Int J Stroke. 2022 Aug;17(7):806-809. doi: 10.1177/17474930211042700. Epub 2021 Sep 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | eptacog alfa (activated) | Protein / enzyme biologic | 80 ug/kg | Intravenous |