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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 : Completed
First Posted : March 11, 2020
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE March 8, 2020
First Posted Date  ICMJE March 11, 2020
Last Update Posted Date June 30, 2022
Actual Study Start Date  ICMJE June 15, 2020
Actual Primary Completion Date February 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2020)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • 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 ]
  • Number of participants with covert brain infarcts detected by MRI [ Time Frame: From baseline up to 6 months ]
  • Time from randomization to first occurrence of symptomatic ischemic stroke [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of disabling stroke [ Time Frame: From baseline up to 12 months ]
    Modified ranking score (mRS)≥4
  • Time from randomization to all-cause mortality [ 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 ISTH major bleeding [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of ISTH CRNM bleeding [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of ISTH minor bleeding [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic) [ Time Frame: From baseline up to 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2020)
  • 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 12 months ]
  • Number of participants with covert brain infarcts detected by MRI [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of symptomatic ischemic stroke [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of disabling stroke [ Time Frame: From baseline up to 12 months ]
    Modified ranking score (mRS)≥4
  • Time from randomization to all-cause mortality [ 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 ISTH major bleeding [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of ISTH CRNM bleeding [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of ISTH minor bleeding [ Time Frame: From baseline up to 12 months ]
  • Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic) [ Time Frame: From baseline up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Non-cardioembolic Ischemic Stroke
Intervention  ICMJE
  • Drug: BAY2433334
    Tablet, taken orally once a day.
  • Other: BAY2433334 matching placebo
    Tablet, taken orally once a day.
Study Arms  ICMJE
  • Experimental: BAY2433334 high dose
    Intervention: Drug: BAY2433334
  • Experimental: BAY2433334 medium dose
    Intervention: Drug: BAY2433334
  • Experimental: BAY2433334 low dose
    Intervention: Drug: BAY2433334
  • Placebo Comparator: BAY2433334 matching placebo
    Intervention: Other: BAY2433334 matching placebo
Publications * Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2022)
1808
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2020)
1800
Actual Study Completion Date  ICMJE February 18, 2022
Actual Primary Completion Date February 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   China,   Czechia,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Japan,   Netherlands,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT04304508
Other Study ID Numbers  ICMJE 19766
2019-003431-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Current Responsible Party Bayer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bayer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Population Health Research Institute
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP