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Trial record 92 of 734 for:    warfarin

Cerebral Microbleeds During NOACs or Warfarin Therapy in NVAF Patients With Acute Ischemic Stroke (CMB-NOW) (CMB-NOW)

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ClinicalTrials.gov Identifier: NCT02356432
Recruitment Status : Unknown
Verified October 2016 by Shunya Takizawa, MD, PhD, Tokai University.
Recruitment status was:  Active, not recruiting
First Posted : February 5, 2015
Last Update Posted : October 20, 2016
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Shunya Takizawa, MD, PhD, Tokai University

Brief Summary:

Anticoagulants are generally recognized as a necessary therapy to prevent the recurrence of ischemic stroke in patients with non-valvular atrial fibrillation (NVAF), but in some patients they also cause bleedings, particularly intracranial hemorrhage. One of the independent predictors of intracerebral hemorrhage is the presence of cerebral microbleeds (CMBs); a high incidence of intracerebral hemorrhage is reported in patients with multiple CMBs. Recent study suggested that patients who had CMBs at baseline developed more new CMBs after 2 years (26%), compared with patients (12%) who did not have CMBs at baseline. However, there has been no study on the progression of CMBs in patients receiving so-called novel oral anticoagulants (NOACs).

This study tests the hypothesis that the incidence of hemorrhagic stroke is lower in patients receiving NOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) than in those receiving warfarin, and this difference reflects the difference in the effects of warfarin and NOACs on the progression of CMBs. Towards this goal, we enroll 200 patients with at least one CMB detected by 1.5 T MRI (T2*WI) at baseline, who treated with NOACs or warfarin for 12 months. Primary endpoint is the proportion of subjects with an increased number of CMBs at Month 12 of treatment with NOACs or warfarin. If the results of this study support the efficacy of NOACs in preventing increase of CMBs, this would be of great interest to domestic and overseas clinicians, in view of the potential therapeutic impact, including that for primary prevention of ischemic stroke.


Condition or disease
Ischemic Stroke Atrial Fibrillation Symptomatic

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Cerebral Microbleeds as Predictor of Future Intra-Cerebral Hemorrhage During NOACs or Warfarin Therapy in NVAF Patients With Acute Ischemic Stroke (CMB-NOW)
Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017


Group/Cohort
NOACs group
Medication with dabigatran, rivaroxaban, apixaban, or edoxaban will not be assigned, but will be freely prescribed by each attending doctor based on assessment of the condition of each patient.
Warfarin group
Medication with warfarin: PT-INR should be controlled in accordance with the JCS2008 guideline concerning the drug treatment of atrial fibrillation, that is, INR 2.0 to 3.0 in patients younger than 70 years, or INR 1.6 to 2.6 in patients not younger than 70 years.



Primary Outcome Measures :
  1. Proportion of subjects with an increased number of CMBs at Month 12 of treatment with NOACs or warfarin [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Proportion of subjects with an increased number of CMBs at Month 6 of treatment with NOACs or warfarin [ Time Frame: 6 months ]
  2. The number of new CMBs in subjects with an increased number of CMBs at Months 6 and 12 of treatment with NOACs or warfarin [ Time Frame: 1 year ]
  3. Location of CMBs (infratentorial, deep white matter, and lobar subgroups) in the NOACs and warfarin groups [ Time Frame: 1 year ]
  4. Incidence rate of adverse events [ Time Frame: 1 year ]
    Incidence rate of ischemic events (cerebral infarction, non-CNS embolism, myocardial infarction, etc.), hemorrhagic events (symptomatic intracranial hemorrhage, subarachnoidal hemorrhage, subdural hematoma, subdural hematoma, etc.), and other adverse events



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with NVAF, who had at least one CMB at the time of entry into this study, and were prescribed a NOAC (dabigatran, rivaroxaban, apixaban, or edoxaban) or warfarin for secondary prevention of cerebral infarction or transient ischemic attack within 2 weeks after the onset. This study is an observational study, and the numbers of patients in the NOACs and warfarin groups were not predetermined, though the total number of patients for the study was limited to 200 for practical reasons.
Criteria

Inclusion Criteria:

  1. Diagnosis of NVAF
  2. Diagnosis of cerebral infarction or TIA within 2 weeks after onset
  3. Patients commenced on NOACs or warfarin therapy as a secondary prevention of cerebral infarction or transient ischemic attack, whether or not anticoagulation therapy was used before enrollment in this study
  4. Age ≥20 years and ≤85 years
  5. Ability to give valid consent and to provide consent in writing or availability of relatives to provide surrogate consent.
  6. At least one CMB detected by 1.5 T MRI (T2*WI) before enrollment in this study

Exclusion Criteria:

  1. Patients using aspirin or other antiplatelet agents concomitantly
  2. Patients in whom NOAC or warfarin is contraindicated
  3. Patients with renal dysfunction (CrCL <15 mL/min)
  4. Patients with uncontrollable hypertension
  5. Patients who are otherwise ineligible to take part in this study as judged by the study doctor

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): NCT02356432


Locations
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Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Kitasato University Hospital
Sagamihara, Kanagawa, Japan, 252-0373
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Sponsors and Collaborators
Tokai University
Daiichi Sankyo, Inc.
Investigators
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Principal Investigator: Shunya Takizawa, MD, PhD Tokai University School of Medicine

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shunya Takizawa, MD, PhD, Professor, Division of Neurology, Department of Internal Medicine, Tokai University School of Medicine, Tokai University
ClinicalTrials.gov Identifier: NCT02356432     History of Changes
Other Study ID Numbers: 14R-155
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shunya Takizawa, MD, PhD, Tokai University:
non-valvular atrial fibrillation
cerebral microbleeds
warfarin
NOACs
acute ischemic stroke
Additional relevant MeSH terms:
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Warfarin
Stroke
Cerebral Infarction
Atrial Fibrillation
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Anticoagulants