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

Completed · Phase 3

Conditions studied: Hemorrhage, Urgent Surgery, Invasive Procedure

In brief

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.

Key facts

Study ID: NCT04286438
Run by: SFJ Pharmaceuticals, Inc.
People needed: 226
Starts: 2020-07-15
Expected to finish: 2024-09-09
Last updated by the study team: 2024-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients will be eligible for inclusion into the study if they meet all of the following criteria:
Male or female >18 years of age with documented or verbal informed consent. Emergency consent may be obtained where permitted by local regulations and institutional approval.
History or documentation of ticagrelor intake within the prior 3 days
Patients described below who require urgent reversal of the antiplatelet effects of ticagrelor:
Patients with uncontrolled major or life-threatening bleeding, requiring urgent reversal of the antiplatelet effects of ticagrelor. It is expected that enrolled patients would have characteristics similar to those described below:
Potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise, e.g., systolic blood pressure < 90 mm Hg and signs or symptoms of low cardiac output not otherwise explained
Bleeding in a critical organ or closed space, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular bleed with compartment syndrome
Visible, uncontrolled bleeding associated with a corrected hemoglobin level < 8.0 g/dL, a fall in hemoglobin level of ≥ 2.0 g/dL (1.24 mmol/L) from a known baseline, or requirement for transfusion of 2 or more units of packed red blood cells (PRBC)
Patients requiring urgent surgery or invasive procedure when it is not medically advisable either to proceed urgently with impaired hemostasis or to delay the urgent procedure for 3 or more days due to the high risk of bleeding. These patients may typically be in any of the following clinical situations:
Requires urgent surgery or invasive procedure known to be associated with a risk of significant bleeding (such as cardiac surgery, neurosurgery, or major orthopedic surgery)
Requires urgent surgery or invasive procedure that may have an adverse procedural outcome if hemostasis is impaired (such as neurological, spinal, ophthalmological, urological, or orthopedic surgery)
At risk of experiencing life-threatening events, such as, shock, myocardial infarction, or stroke, if significant intraoperative or postoperative bleeding occurs (such as in elderly patients or patients with underlying cardiac or pulmonary disease who have limited cardiopulmonary reserve)

You may not qualify if…

Known sensitivity or contraindication to PB2452 or any of its excipients
Patients in whom ticagrelor reversal is not considered urgent, e.g., patients with stable or non-acute conditions who have low hemoglobin due to chronic, low-grade gastrointestinal bleeding or who have stable, remote, or asymptomatic intracranial hemorrhage
Patients expected to be clinically unsalvageable, such as, patients with end-stage cancer or patients with overwhelming sepsis
Any condition which, in the opinion of the investigator, would make it unsafe or unsuitable for the patients to participate in this study. This includes assessment of likelihood to cooperate with study follow-up visits and procedures. Known pregnancy may be exclusionary in some regions or countries as directed by national health authorities and/or local Institutional Review Boards/Ethics Committees
Known use of clopidogrel, prasugrel or ticlopidine within 5 days of study drug administration; known use of antiplatelet GPIIb/IIIa inhibitors, or cangrelor within 5 half-lives of expected study drug administration; or known use of warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 5 half-lives of expected study drug administration
Known recent use (< 5 day) of vitamin K, prothrombin complex concentrate, recombinant factor VIIa, idarucizumab, or andexanet-alfa (coagulation factor Xa (recombinant), inactivated-zhzo)

Where it is running

University of Kentucky — Lexington, Kentucky, United States
Sinai Hospital of Baltimore — Baltimore, Maryland, United States
Henry Ford Hospital — Detroit, Michigan, United States
North Kansas City Hospital — North Kansas City, Missouri, United States
Cox Medical Centers — Springfield, Missouri, United States
Sanford Medical Center Fargo — Fargo, North Dakota, United States
Ascension St. John Clinical Research Institute — Tulsa, Oklahoma, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Medical University Of Graz — Graz, STY, Austria
Klinische Abteilung für Innere Medizin 3 Universitätsklinikum St. Pölten — Sankt Pölten, Austria
Klinik Ottakring 3rd Med Dept, Cardiology and Intensive Care Medicine — Vienna, Austria
Algemeen Stedelijk Ziekenhuis (ASZ) Study Center Cardiology — Aalst, East Flanders, Belgium
Ziekenhuis Oost-Limburg Study Center Intensive Care — Genk, Limburg, Belgium
AZ Sint-Jan Brugge-Oostende AV Poli Cardiologie — Bruges, Belgium
University Hospital Antwerp Cardiology Department - Clinical Trials — Edegem, Belgium
Jessa Hospital Hartcentrum Hasselt Research Center — Hasselt, Belgium
Foothills Medical Centre — Calgary, Alberta, Canada
Saint John Regional Hospital — Saint John, New Brunswick, Canada
William Osler Health System — Etobicoke, Ontario, Canada
Hamilton Health Sciences Centre — Hamilton, Ontario, Canada
Kingston Health Science Centre — Kingston, Ontario, Canada
York PCI Group, Inc. — Newmarket, Ontario, Canada
St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada
Toronto General Hospital — Toronto, Ontario, Canada
University of Florida Health, Jacksonville — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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