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)

JRCT ID: jRCT2080225213

Registered date:01/06/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Acute myocardial infarction
• Date of first enrollment: 16/03/2020
• Target sample size: 1600
• Countries of recruitment: Japan,North America,Europe
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : BAY 2433334
INN of investigational material : -
Therapeutic category code : 333 Anticoagulants
Dosage and Administration for Investigational material : Tablet, taken orally once a day.

control material(s)
Generic name etc : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Tablet, taken orally once a day.

Outcome(s)

Primary Outcome

safety
efficacy
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]
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

safety
efficacy
Time from randomization to death (all cause mortality) [Time Frame: From baseline up to 12 months]
Time from randomization to CV death [Time Frame: From baseline up to 12 months]
Time from randomization to first occurrence of MI [Time Frame: From baseline up to 12 months]
Time from randomization to first occurrence of stroke (ischemic and hemorrhagic) [Time Frame: From baseline up to 12 months]
Time from randomization to first occurrence of stent thrombosis [Time Frame: From baseline up to 12 months]
Time from randomization to first occurrence of all bleeding [Time Frame: From baseline up to 12 months]
Time from randomization to first occurrence of BARC bleeding definition Type 3, 5 [Time Frame: From baseline up to 12 months]
Time from randomization to first occurrence of BARC bleeding definition Type 1, 2, 3, 5 [Time Frame: From baseline up to 12 months]

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Bayer Yakuhin, Ltd.
• Secondary ID(s): NCT04304534,JapicCTI-205309