ANNEXA-4

• Research type

  Research Study

• Full title

  Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4).

• IRAS ID

  184139

• Contact name

  Raza Alikhan

• Contact email

  Raza.Alikhan@wales.nhs.uk

• Sponsor organisation

  Portola Pharmaceuticals, Inc.

• Eudract number

  2015-001785-26

• Clinicaltrials.gov Identifier

  NCT02329327

• Clinicaltrials.gov Identifier

  INJU 4681, CSP/NIHR

• Duration of Study in the UK

  6 years, 4 months, 0 days

• Research summary

  This study is being conducted to determine the safety and effectiveness of andexanet alfa in patients on a blood thinning drug who are experiencing a bleeding event. Andexanet is a recombinant, modified human protein that is a replica of factor Xa, a protein in blood that plays a key role in normal blood clotting. Andexanet is being developed as an antidote to reverse the effects of certain blood thinner drugs. Andexanet works by binding to the blood thinner drug so the blood thinner drug is no longer able to interfere with the blood clotting process.
  To participate in this study, Patients will have been previously prescribed one of four blood thinner drugs: apixaban (also known as Eliquis®), rivaroxaban (also known as Xarelto®), edoxaban (also known as Sayvasa® or Lixiana®), or enoxaparin (also known as Lovenox® or Clexane®), and be currently experiencing bleeding that is severe enough and recent enough to qualify for the study.
  The main objectives of this study are to:
  • Find out how well andexanet reverses the effect of blood thinner drugs in patients who are bleeding after having taken one of the blood thinner drugs listed above.
  • Find out how well andexanet helps to stop bleeding
  • To learn about the safety of andexanet in patients who are bleeding

  This study will enroll up to approximately 270 patients at approximately 120 hospitals in the United States, Europe, and Canada. Patient’s participation in this study will last about 30-37 days and will stay in the hospital for as long as the doctors thinks the patient needs to - this is not affected by the study. However, whether or not the patient is still in the hospital, they will need to have follow-up visit for the study in about 3 days and again in about 4 weeks.

• REC name

  Wales REC 3

• REC reference

  15/WA/0324

• Date of REC Opinion

  13 Oct 2015

• REC opinion

  Further Information Favourable Opinion