Multicenter, randomized, placebo controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate the efficacy and safety of BAY 2433334 in patients following an acute myocardial infarction(PACIFIC-AMI)
- Conditions
- Acute myocardial infarction
- Registration Number
- JPRN-jRCT2080225213
- Lead Sponsor
- Bayer Yakuhin, Ltd.
- Brief Summary
The primary efficacy objective was not met as asundexian (20 mg and 50 mg pooled) did not result in lower incidences of primary efficacy composite events of CV death, MI, stroke and stent thrombosis compared with placebo. The bleeding risk of asundexian was favorable on top of standard of care (DAPT), even with near complete inhibition of FXIa activity in the 50 mg asundexian dose group. Overall asundexian shows a favorable safety profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1601
Inclusion Criteria:
- Participants must be 45 years of age or older, at the time of signing theinformed consent
- Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with:
-- clinical symptoms of acute myocardial infarction AND
-- elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND
-- at least one of the following risk factors need to be fulfilled:
--- Age >= 65 years
--- Prior MI (before the index AMI event)
--- Prior peripheral arterial disease
--- Diabetes Mellitus
--- Prior coronary artery bypass grafting (CABG)
AND
-- initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization.
(Note: a planned, staged PCI procedure can be performed after randomization)
- Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI
- Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.
Exclusion Criteria:
- Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization
- Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization
- Planned use or requirement of full dose and long term anticoagulation therapy during study conduct
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Time from randomization to first occurrence of any of the components of the composite outcome including Cardiovascular (CV) death, Myocardial infarction (MI), stroke and stent thrombosis [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding definition type 2, 3 and 5 [Time Frame: From baseline up to 12 months]
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Time from randomization to death (all cause mortality) [Time Frame: From baseline up to 12 months]<br>Time from randomization to CV death [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of MI [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of stroke (ischemic and hemorrhagic) [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of stent thrombosis [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of all bleeding [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of BARC bleeding definition Type 3, 5 [Time Frame: From baseline up to 12 months]<br>Time from randomization to first occurrence of BARC bleeding definition Type 1, 2, 3, 5 [Time Frame: From baseline up to 12 months]