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
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
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||86 participants|
|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|
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.
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.
- Proportion of subjects with an increased number of CMBs at Month 12 of treatment with NOACs or warfarin [ Time Frame: 1 year ]
- Proportion of subjects with an increased number of CMBs at Month 6 of treatment with NOACs or warfarin [ Time Frame: 6 months ]
- 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 ]
- Location of CMBs (infratentorial, deep white matter, and lobar subgroups) in the NOACs and warfarin groups [ Time Frame: 1 year ]
- 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
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
|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|
|Principal Investigator:||Shunya Takizawa, MD, PhD||Tokai University School of Medicine|