This protocol was contributed by a third party and has not been verified. Provided for informational and standards-development purposes only — see the Disclaimer & Terms of Use.

BAY19766 (Bayer) - Move to Production

Status & Metadata
Source Method : Publicly Available
Source URL: Link
Generation Method : Unknown
Date Added: 16 Jun 2026
Contributor: System
View USDM Protocol Download JSON
Additional Resources
Protocol
Date Added: 16 Jun 2026
CDISC CORE Conformance
Conformance assessed
SKIPPED 48
SUCCESS 144
ISSUE_REPORTED 10
EXECUTION_ERROR 5
Download Excel report Download JSON report

Rationale

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

Key Metrics

Interventional Study
Phase IIb Trial
1.0
0f355702-3b06-4ecb-8ad0-978f6312fec4

Important Dates

Event Date
Protocol Approval 01 Jan 2024

Schedule of Activities: Main Study Design

Timeline: Main
Visit / Timing Interval Window Activities
Intervention Period Day 1.0
TIM1 		1 day No window
  • Informed Consent Obtained
  • Informed Consent, Pharmacogenetic (PGx) Testing
  • Participant Contact Card
  • Inclusion/Exclusion Criteria
  • Demographics
  • Vital Signs
  • Body Height
  • Body Weight
  • Medical History, General (Lifetime)
  • Prior/Concomitant Medications
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • 12 Lead ECG
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
Intervention Period Day 15.0
TIM2 		1 day No window
  • Concomitant Medications
  • Inclusion/Exclusion Criteria
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • 12 Lead ECG
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • MRI, Brain, Diffusion Weighted Imaging (DWI)
  • IRT - Randomization
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • PD Sampling
  • Pharmacogenetic DNA Analysis Panel
  • C Reactive Protein [Mass/Vol] by HSM
  • Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol]
  • Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method
  • Complement C1 Esterase Inhibitor [Mass/Vol]
  • Thrombin Antithrombin Complex Ag [Mass/Vol]
  • Prothrombin Fragment 1.2 Ag [Moles/Vol]
  • Investigational Product Dispensation
  • IP Administration - Oral Tablet
  • MRI, Brain W Contrast
  • aPTT by Coagulation Assay
  • Fibrin D-Dimer DDU [Mass/Vol]
  • Coagulation Factor XI Ag [Units/volume] by Immunoassay
  • Factor XII Ag [Unit/Vol]
  • vWf Ag [Unit/Vol] by Immunologics
  • vWf Ristocetin Cofactor Actual/Norm
Intervention Period Day 29.0
TIM3 		1 day No window
  • Concomitant Medications
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Participant Contact
Intervention Period Day 57.0
TIM4 		1 day No window
  • Concomitant Medications
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • PK Sampling
  • PD Sampling
  • IP Administration - Oral Tablet
  • aPTT by Coagulation Assay
  • Fibrin D-Dimer DDU [Mass/Vol]
  • Coagulation Factor XI Ag [Units/volume] by Immunoassay
  • Factor XII Ag [Unit/Vol]
  • vWf Ag [Unit/Vol] by Immunologics
  • vWf Ristocetin Cofactor Actual/Norm
Intervention Period Day 92.0
TIM5 		1 day No window
  • Concomitant Medications
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Participant Contact
Intervention Period Day 141.0
TIM6 		1 day No window
  • Concomitant Medications
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • 12 Lead ECG
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • MRI, Brain, Diffusion Weighted Imaging (DWI)
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • Investigational Product Dispensation
  • Investigational Product Accountability
  • Investigational Product Return
  • MRI, Brain W Contrast
Intervention Period Day 183.0
TIM7 		1 day No window
  • Concomitant Medications
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Participant Contact
Intervention Period Day 225.0
TIM8 		1 day No window
  • Concomitant Medications
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • MRI, Brain, Diffusion Weighted Imaging (DWI)
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • PK Sampling
  • PD Sampling
  • C Reactive Protein [Mass/Vol] by HSM
  • Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol]
  • Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method
  • Complement C1 Esterase Inhibitor [Mass/Vol]
  • Thrombin Antithrombin Complex Ag [Mass/Vol]
  • Prothrombin Fragment 1.2 Ag [Moles/Vol]
  • Investigational Product Dispensation
  • IP Administration - Oral Tablet
  • Investigational Product Accountability
  • Investigational Product Return
  • MRI, Brain W Contrast
  • aPTT by Coagulation Assay
  • Fibrin D-Dimer DDU [Mass/Vol]
  • Coagulation Factor XI Ag [Units/volume] by Immunoassay
  • Factor XII Ag [Unit/Vol]
  • vWf Ag [Unit/Vol] by Immunologics
  • vWf Ristocetin Cofactor Actual/Norm
  • Pharmacogenetic DNA Analysis Panel
Intervention Period Day 274.0
TIM9 		1 day No window
  • Concomitant Medications
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Participant Contact
Intervention Period Day 323.0
TIM10 		1 day No window
  • Concomitant Medications
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • Investigational Product Dispensation
  • Investigational Product Accountability
  • Investigational Product Return
Intervention Period Day 365.0
TIM11 		1 day No window
  • Concomitant Medications
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Participant Contact
Intervention Period
TIM12 		1 day No window
  • Concomitant Medications
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • 12 Lead ECG
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Creatine Kinase [Act/Vol]
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • Investigational Product Accountability
  • Investigational Product Return
Safety Follow-up (SFU) Day 14.0
TIM13 		1 day No window
  • Vital Signs
  • Concomitant Medications
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • 12 Lead ECG
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • MRI, Brain, Diffusion Weighted Imaging (DWI)
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • Creatine Kinase [Act/Vol]
  • PK Sampling
  • PD Sampling
  • C Reactive Protein [Mass/Vol] by HSM
  • Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol]
  • Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method
  • Complement C1 Esterase Inhibitor [Mass/Vol]
  • Thrombin Antithrombin Complex Ag [Mass/Vol]
  • Prothrombin Fragment 1.2 Ag [Moles/Vol]
  • Investigational Product Accountability
  • Investigational Product Return
  • MRI, Brain W Contrast
  • aPTT by Coagulation Assay
  • Fibrin D-Dimer DDU [Mass/Vol]
  • Coagulation Factor XI Ag [Units/volume] by Immunoassay
  • Factor XII Ag [Unit/Vol]
  • vWf Ag [Unit/Vol] by Immunologics
  • vWf Ristocetin Cofactor Actual/Norm
Safety Follow-up (SFU) Day 14.0
TIM14 		1 day No window
  • Vital Signs
  • Concomitant Medications
  • Modified Rankin Scale
  • National Institute of Health Stroke Scale (NIHSS)
  • 12 Lead ECG
  • Vital Signs
  • Adverse Events
  • Cardiovascular Clinical Events Assessment
  • MRI, Brain, Diffusion Weighted Imaging (DWI)
  • Contact IXRS
  • CBC W Differential Panel (Automated)
  • Chemistry Panel (CHEM-20)
  • Lipase [Act/Vol]
  • Amylase [Act/Vol]
  • Lipid Panel
  • Thyrotropin (TSH) [Unit/Vol]
  • Creatine Kinase [Act/Vol]
  • PK Sampling
  • PD Sampling
  • C Reactive Protein [Mass/Vol] by HSM
  • Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol]
  • Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method
  • Complement C1 Esterase Inhibitor [Mass/Vol]
  • Thrombin Antithrombin Complex Ag [Mass/Vol]
  • Prothrombin Fragment 1.2 Ag [Moles/Vol]
  • Investigational Product Accountability
  • Investigational Product Return
  • MRI, Brain W Contrast
  • aPTT by Coagulation Assay
  • Fibrin D-Dimer DDU [Mass/Vol]
  • Coagulation Factor XI Ag [Units/volume] by Immunoassay
  • Factor XII Ag [Unit/Vol]
  • vWf Ag [Unit/Vol] by Immunologics
  • vWf Ristocetin Cofactor Actual/Norm