Protocol 18-513 Andexanet ICH
Research type
Research Study
Full title
A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
IRAS ID
256470
Contact name
Thompson Robinson
Contact email
Sponsor organisation
Portola Pharmaceuticals, Inc
Eudract number
2018-002620-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 18 days
Research summary
Research Summary:
Andexanet, is an intravenous specific antidote for blood thinning drug known as a Factor Xa inhibitor. Andexanet has been approved for use in the United States as a reversal agent for patients who have taken the blood thinning drugs, rivaroxaban or apixaban and who are experiencing a serious or life-threatening bleeding episode. This study is intended to determine whether andexanet is more effective than usual care to stop bleeding in this setting. The study will enrol approximately 440 patients with intracranial bleeding who are taking Factor Xa inhibitors.
Participants will receive either andexanet or usual care at the hospital for their bleeding condition. The treatment they receive will be chosen randomly. For patients randomized to usual care treatment, pro-coagulant factor infusions, whole blood, and platelet transfusions may be administered according to standard local practice.
If patients receive andexanet it will be given in one of two doses, a low dose or a high dose. The dose of andexanet that patient receive will depend on which Factor Xa blood thinner drug they normally take, and when they last took the drug. In this study, andexanet will only be given once.
Patient's participation in this study will most likely last about 30-37 days, but could be as many as 90-120 days. Blood samples will be taken about 6 times during the study and vital signs will be monitored throughout the study. Computed Tomography or Magnetic Resonance Imaging scan of the head will be done upon arrival to hospital and 12h after randomization.Summary of results:
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.trialsummaries.com%252FHome%252FLandingPage%2FNBTI%2FaDW3AQ%2FAQ%2F0829c047-b48c-491f-9aff-c8cba9f8c16a%2F1%2FsdY1izlhFn&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7C09f4d943eabc463e5e2508dcb7ec7aac%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638587473495654214%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=G6NK2VPWJGlq26%2B2jm%2BtqyH6tBIpqhYpDdfYX0KBP4g%3D&reserved=0
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0094
Date of REC Opinion
11 Jun 2019
REC opinion
Further Information Favourable Opinion