Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery… (NCT04286438) | Clinical Trial Compass
CompletedPhase 3
Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or Invasive Procedure
United States226 participantsStarted 2020-07-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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:
Exclusion criteria
✕. 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
What they're measuring
1
Reversal - Platelet Reactivity Units (PRU)
Timeframe: 4 hours post-initiation of infusion
2
Hemostasis - Uncontrolled major of life-threatening bleeding - Achievement
Timeframe: 4 hours post-initiation of infusion
3
Hemostasis - Urgent surgery or invasive procedure - Achievement
✕. 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)