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Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (PACIFIC-AMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304534
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: BAY2433334 Other: BAY2433334 matching placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : February 12, 2022
Estimated Study Completion Date : February 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: BAY 2433334 high dose Drug: BAY2433334
Tablet, taken orally once a day.

Experimental: BAY 2433334 medium dose Drug: BAY2433334
Tablet, taken orally once a day.

Experimental: BAY 2433334 low dose Drug: BAY2433334
Tablet, taken orally once a day.

Placebo Comparator: BAY2433334 matching placebo Other: BAY2433334 matching placebo
Tablet, taken orally once a day.




Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. Time from randomization to death (all cause mortality) [ Time Frame: From baseline up to 12 months ]
  2. Time from randomization to CV death [ Time Frame: From baseline up to 12 months ]
  3. Time from randomization to first occurrence of MI [ Time Frame: From baseline up to 12 months ]
  4. Time from randomization to first occurrence of stroke (ischemic and hemorrhagic) [ Time Frame: From baseline up to 12 months ]
  5. Time from randomization to first occurrence of stent thrombosis [ Time Frame: From baseline up to 12 months ]
  6. Time from randomization to first occurrence of all bleeding [ Time Frame: From baseline up to 12 months ]
  7. Time from randomization to first occurrence of BARC bleeding definition Type 3, 5 [ Time Frame: From baseline up to 12 months ]
  8. Time from randomization to first occurrence of BARC bleeding definition Type 1, 2, 3, 5 [ Time Frame: From baseline up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be 45 years of age or older, at the time of signing the informed 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304534


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04304534    
Other Study ID Numbers: 20603
2019-003244-79 ( EudraCT Number )
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases