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Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) (NAVIGATE ESUS)

This study has been terminated.
(Study halted early due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study were completed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02313909
First Posted: December 10, 2014
Last Update Posted: October 23, 2017
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. Read our disclaimer for details.
Collaborators:
Janssen, LP
Hamilton Health Sciences Cooperation, Population Health Research Institute
Information provided by (Responsible Party):
Bayer
  Purpose
This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Condition Intervention Phase
Stroke Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin (Acetylsalicylic acid, BAY1019036) Other: Rivaroxaban-Placebo Other: Aspirin-Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time from randomization to first occurrence of any of the components of the composite outcome (adjudicated), including: Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging), Systemic embolism [ Time Frame: Approximately 3 years ]
  • Time from randomization to the first occurrence of major bleeding (acc. to the International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 3 years ]

Secondary Outcome Measures:
  • Time from randomization to first occurrence of any of the following: Cardiovascular death (including death due to hemorrhage), recurrent stroke, systemic embolism, and myocardial infarction [ Time Frame: Approximately 3 years ]
  • Time from randomization to first occurrence of: All cause mortality [ Time Frame: Approximately 3 years ]
  • Time from randomization to first occurrence of: Individual components of the primary and secondary efficacy outcomes (stroke, CV death, and myocardial infarction) as well as ischemic stroke, and disabling stroke (modified Rankin score 4 and 5) [ Time Frame: Approximately 3 years ]
  • Time from randomization to the first occurrence of life-threatening bleeding [ Time Frame: Approximately 3 years ]
  • Time from randomization to the first occurrence of clinically relevant non-major bleeding [ Time Frame: Approximately 3 years ]
  • Time from randomization to the first occurrence of intracranial hemorrhage [ Time Frame: Approximately 3 years ]

Enrollment: 6934
Actual Study Start Date: December 23, 2014
Estimated Study Completion Date: December 15, 2017
Estimated Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Rivaroxaban 15 mg orally once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily, orally, tablet
Other: Rivaroxaban-Placebo
Matching placebo, once daily, orally, tablet
Active Comparator: Aspirin
Aspirin 100 mg orally once daily
Drug: Aspirin (Acetylsalicylic acid, BAY1019036)
100 mg, once daily, orally, tablet
Other: Aspirin-Placebo
Matching placebo, once daily, orally, tablet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent ESUS (between 7 days and 6 months), defined as:
  • Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
  • Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and
  • No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
  • No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
  • No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)

Exclusion Criteria:

  • Severely disabling stroke (modified Rankin score ≥4)
  • Indication for chronic anticoagulation or antiplatelet therapy
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
  Contacts and Locations
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): NCT02313909


  Show 546 Study Locations
Sponsors and Collaborators
Bayer
Janssen, LP
Hamilton Health Sciences Cooperation, Population Health Research Institute
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02313909     History of Changes
Other Study ID Numbers: 16573
2013-000768-27 ( EudraCT Number )
First Submitted: December 8, 2014
First Posted: December 10, 2014
Last Update Posted: October 23, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Rivaroxaban
Xarelto
Aspirin
ASA
Oral Anticoagulant
Blood Thinner
Stroke
Ischemic Stroke
Cryptogenic Stroke
Embolic stroke of undetermined source
ESUS
Transient Ischemic Attack
Thromboembolism
Cerebrovascular Disease

Additional relevant MeSH terms:
Stroke
Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Aspirin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors