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Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain. (PACIFIC-STROKE)

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ClinicalTrials.gov Identifier: NCT04304508
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Population Health Research Institute
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 antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. 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 Non-cardioembolic Ischemic Stroke Drug: BAY2433334 Other: BAY2433334 matching placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 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 Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022

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

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

Experimental: BAY2433334 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. Number of participants with symptomatic ischemic stroke or covert brain infarcts detected by Magnetic resonance imaging (MRI) [ Time Frame: From baseline up to 6 months ]
  2. Time from randomization to first occurrence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding [ Time Frame: From baseline up to 12 months ]

Secondary Outcome Measures :
  1. Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, Cardiovascular (CV) death, myocardial infarction and systemic embolism [ Time Frame: From baseline up to 6 months ]
  2. Number of participants with covert brain infarcts detected by MRI [ Time Frame: From baseline up to 6 months ]
  3. Time from randomization to first occurrence of symptomatic ischemic stroke [ Time Frame: From baseline up to 12 months ]
  4. Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction [ Time Frame: From baseline up to 12 months ]
  5. Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke [ Time Frame: From baseline up to 12 months ]
  6. Time from randomization to first occurrence of disabling stroke [ Time Frame: From baseline up to 12 months ]
    Modified ranking score (mRS)≥4

  7. Time from randomization to all-cause mortality [ Time Frame: From baseline up to 12 months ]
  8. Time from randomization to first occurrence of all bleeding [ Time Frame: From baseline up to 12 months ]
  9. Time from randomization to first occurrence of ISTH major bleeding [ Time Frame: From baseline up to 12 months ]
  10. Time from randomization to first occurrence of ISTH CRNM bleeding [ Time Frame: From baseline up to 12 months ]
  11. Time from randomization to first occurrence of ISTH minor bleeding [ Time Frame: From baseline up to 12 months ]
  12. Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic) [ 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:

  • Participant must be 45 years of age and older at the time of signing the informed consent
  • Non-cardioembolic ischemic stroke with

    • persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
    • acute brain infarction documented by computed tomography (CT) or MRI AND
    • with the intention to be treated with antiplatelet therapy during the study conduct
  • Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
  • Severity of index event nearest the time of randomization:

    • Part A: minor stroke (defined as National Institutes of Health Stroke Scale (NIHSS) ≤ 7) can be enrolled
    • Part B: participants with minor or moderate stroke and NIHSS ≤ 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention
  • Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
  • Ability to conduct an MRI either before randomization or within 72 hours after randomization

Exclusion Criteria:

  • Prior ischemic stroke within last 30 days of index event
  • History of atrial fibrillation or suspicion of cardioembolic source of stroke
  • Dysphagia with inability to safely swallow study medication
  • Contraindication to perform brain MRI
  • Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
  • Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization.

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): NCT04304508


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
Population Health Research Institute
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04304508    
Other Study ID Numbers: 19766
2019-003431-33 ( EudraCT Number )
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 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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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia