Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or Invasive Procedure

Summary

This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. At least 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria.

Timeline

Start

2020-07-15

Primary completion

2024-09-09

Completion

2024-09-09

Publications

• Bhatt DL, Pollack CV, Mazer CD, Angiolillo DJ, Steg PG, James SK, Weitz JI, Ramnath R, Arnold SE, Mays MC, Umstead BR, White B, Hickey LL, Jennings LK, Curry BJ, Lee JS, Verma S. Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery. NEJM Evid. 2022 Mar;1(3):EVIDoa2100047. doi: 10.1056/EVIDoa2100047. Epub 2021 Dec 1.

Drugs

Indications