Protocol for Cerebral Microbleeds during the Non-Vitamin K Antagonist Oral Anticoagulants or Warfarin Therapy in Stroke Patients with Nonvalvular Atrial Fibrillation (CMB-NOW) Study: Multisite Pilot Trial
| Autor: | Kazutoshi Nishiyama, Yasuhiro Hasegawa, Kazuo Kitagawa, Atsushi Mizuma, Taira Nakayama, Shunya Takizawa, Takashi Okazaki, Fumiaki Tanaka, Hiroyuki Kobayashi, Eiichiro Nagata, Sachiko Yutani, Noriharu Yanagimachi |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty medicine.drug_class Administration Oral Pilot Projects Dabigatran chemistry.chemical_compound Edoxaban Internal medicine Atrial Fibrillation medicine Humans Longitudinal Studies Stroke Aged Cerebral Hemorrhage Intracerebral hemorrhage Aged 80 and over business.industry Rehabilitation Anticoagulant Warfarin Anticoagulants Vitamin K antagonist medicine.disease Magnetic Resonance Imaging Treatment Outcome chemistry Anesthesia Cardiology Surgery Apixaban Female Neurology (clinical) Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 24(9) |
| ISSN: | 1532-8511 |
| Popis: | Rationale Anticoagulants are widely used to prevent recurrence of ischemic stroke in patients with nonvalvular atrial fibrillation, but in some patients, they also cause bleeding, 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 warfarin-treated patients with multiple CMBs. Longitudinal study suggested that the presence of CMBs at baseline is a predictor of new CMBs in warfarin-treated patients. However, there has been no study on the progression of CMBs in patients receiving the non–vitamin K antagonist oral anticoagulants (NOACs). Aims 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. Design We will enroll 200 patients with at least 1 CMB detected by 1.5 T magnetic resonance imaging ( T 2 ∗ -weighted imaging) at baseline and who have received NOACs or warfarin for at least 12 months. Primary end point 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 for preventing increase of CMBs, this would be of great interest to domestic and overseas clinicians, in view of the potential therapeutic impact, including that on primary prevention of ischemic stroke. |
| Databáze: | OpenAIRE |
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