Ischemic StrokeCMB-NOWNCT02356432

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

An observational study of Ischemic Stroke and Atrial Fibrillation Symptomatic, run by Tokai University at 3 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Ischemic Stroke, Atrial Fibrillation Symptomatic
How many people: 86 participants
Where: 3 sitesJapan
Study dates: Mar 2015to Sep 2017
How long will I take part?: 1 Year
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

Diagnosis of NVAF
Diagnosis of cerebral infarction or TIA within 2 weeks after onset
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
Age ≥20 years and ≤85 years
Ability to give valid consent and to provide consent in writing or availability of relatives to provide surrogate consent.
At least one CMB detected by 1.5 T MRI (T2*WI) before enrollment in this study

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0373
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

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)

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.

Read the detailed description

Introduction 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 (including intracerebral 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 (Soo et al, J Neurol, 2008; Lee et al, Neurology, 2009) Also, the rate and absolute number of CMBs increase in proportion to CHADS2 score in patients with cerebral infarction accompanying NVAF (Song et al, Eur J Neurol, 2013). Among CMB-positive patients, a high incidence of intracranial hemorrhage associated with oral anticoagulation therapy has been reported (Song et al, Eur J Neurol, 2013); suggesting a relationship between the occurrence or absolute number of CMBs and the development of intracranial hemorrhage during oral anticoagulation therapy. Imaizumi et al. (J Stroke Cerebrovasc Dis, 2013) found that warfarin alone did not increase the incidence of intracerebral hemorrhage in all subjects with CMBs, but subjects with 3 or more deep CMBs did show an increased incidence. Also, a meta-analysis conducted by Lovelock et al. (Stroke, 2010) demonstrated a higher incidence of CMBs in patients with intracerebral hemorrhage receiving warfarin than in patients with intracerebral hemorrhage not receiving antithrombotic therapy. Recently, Orken et al (Clin Neurol Neurosurg, 2013) 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 (p=0.03). However, there has been no study on the progression of CMBs in patients receiving so-called novel oral anticoagulants (NOACs). NOACs, including dabigatran (Hart et al, Stroke 2012), rivaroxaban (Patel et al, N Engl J Med 2011), apixaban (Granger CB et al, N Engl J Med 2011), and edoxaban (Giugliano et al, N Engl J Med 2013), are superior to warfarin in preventing stroke or systemic embolism in patients with NVAF, and have been reported to significantly reduce the incidence of hemorrhagic stroke. Therefore, this study was designed to evaluate and compare the absolute number of CMBs in patients with at least one CMB at baseline, who receive anticoagulant therapy with NOACs and with warfarin. The correlation between CMBs and intracranial hemorrhage, as well as the status of CMBs before commencement of treatment and their progression during treatment, will be evaluated to determine whether there are differences between the two groups.
The feature of this study Japan has a very high availability of MRI facilities, and thus CMBs can be readily evaluated in multiple patients using T2*WI. As of January 1, 2013, the total population of Kanagawa Prefecture was 9.07 million, of whom the elderly (≥65 years) comprised 1.95 million; therefore, a clinical observational study covering this prefecture that revealed a significant difference between NOACs and warfarin should have a substantial impact on drug-prescribing practice. CMBs found on T2*-weighted gradient-echo MRI 1.5 Tesla should be evaluated. The imaging data will be evaluated by the Cerebral Microbleeds Evaluation Committee using the assessment scale of Gregoire et al. under a blinded condition.
Study design This study tests the hypothesis that the incidence of hemorrhagic stroke is lower in patients receiving NOACs than in those receiving warfarin, and this difference reflects the difference in the effects of warfarin and NOACs on the progression of CMBs in patients with at least one CMB. 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. 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. For quality assurance, data validation and registry procedures including any plans for site monitoring and auditing is performed.
Sample Size and Sample Size Justification Orken et al. (Clin Neurol Neurosurg, 2013) suggested that more patients who had CMBs at baseline developed new CMBs (26%) after 2 years, compared with patients (12%) who did not have CMBs at baseline. Therefore, the rate of new CMBs in warfarin-treated patients who had at least one CMB at baseline was assumed to be 13% in 1-year follow-up. Meanwhile, in the ENGAGE AF-TIMI study, the incidence of intracranial hemorrhage among patients receiving edoxaban (one of the NOACs) was about half of that in patients receiving warfarin; the rate of appearance of new CMBs was assumed to be 6.5%. Simulations (10,000 times) indicated that the probability that the rank order of the rate of newly developed CMBs in 1 year would not be reversed between the two groups was 92.7% (power: 19%, two-sided α= 0.05). As this is a pilot study, the number of necessary subjects was estimated to be 100 subjects in 1 group and 200 in 2 groups combined, based on the above results.
Statistical Analysis plan For proportion with new CMBs at month 6 and at month 12, number of new CMBs at months 6 and 12, and location of CMBs, major analyses will be conducted according to the per protocol set (PPS) principle. In addition, for incidence rate of adverse events, major analyses will be conducted according to the intention to treat (ITT) principle. As the primary endpoints analyses (proportion with new CMBs at month 12), the NOACs group and the warfarin group will be compared with respect to total CMBs positive proportion. It' will be also compared between the NOACs group and the warfarin group about the respective secondary endpoints (proportion with new CMBs at month 6, number of new CMBs at months 6 and 12, location of CMBs, incidence rate of adverse events). Proportion of subjects with an increased number of CMBs at month 12 is compared among NOACs. As the need arises, such as the comparison among NOACs, it will be stratified by the factors which are a patient background, the treatment contents and etc., and will be analyzed.

Conditions: Ischemic Stroke, Atrial Fibrillation Symptomatic
Keywords: non-valvular atrial fibrillation, cerebral microbleeds, warfarin, NOACs, acute ischemic stroke
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02356432
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects with an increased number of CMBs at Month 12 of treatment with NOACs or warfarin
Measured: 1 year

Secondary outcomes (4)

Proportion of subjects with an increased number of CMBs at Month 6 of treatment with NOACs or warfarin
Measured: 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
Measured: 1 year
Location of CMBs (infratentorial, deep white matter, and lobar subgroups) in the NOACs and warfarin groups
Measured: 1 year
Incidence rate of adverse events
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
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Sep 2017

First posted5 Feb 2015 (estimated)
Study startMar 2015
Primary completionSep 2016
Study completionSep 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 86 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT02356432
Sponsor's protocol ID: 14R-155
Acronym: CMB-NOW
Status last verified: Oct 2016
First submitted: 1 Feb 2015
Last updated: 20 Oct 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Takizawa S, Tanaka F, Nishiyama K, Hasegawa Y, Nagata E, Mizuma A, Yutani S, Nakayama T, Kobayashi H, Yanagimachi N, Okazaki T, Kitagawa K; CMB-NOW Study Investigators. 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. J Stroke Cerebrovasc Dis. 2015 Sep;24(9):2143-8. doi: 10.1016/j.jstrokecerebrovasdis.2015.05.032. Epub 2015 Jul 4.
PubMed 26153510

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02356432
Acronym / sponsor ID: CMB-NOW / 14R-155
Conditions: Ischemic Stroke, Atrial Fibrillation Symptomatic
Keywords: non-valvular atrial fibrillation, cerebral microbleeds, warfarin, NOACs, acute ischemic stroke
Study type: Observational
Recruitment status: Unknown status
Enrolment: 86 participants (actual)
Lead sponsor: Tokai UniversityUniversity, hospital or other
Collaborators: Daiichi Sankyo
Study start: Mar 2015
Primary completion: Sep 2016 (actual)
Study completion: Sep 2017 (estimated)
First posted: 5 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Introduction 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 (including intracerebral 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 (Soo et al, J Neurol, 2008; Lee et al, Neurology, 2009) Also, the rate and absolute number of CMBs increase in proportion to CHADS2 score in patients with cerebral infarction accompanying NVAF (Song et al, Eur J Neurol, 2013). Among CMB-positive patients, a high incidence of intracranial hemorrhage associated with oral anticoagulation therapy has been reported (Song et al, Eur J Neurol, 2013); suggesting a relationship between the occurrence or absolute number of CMBs and the development of intracranial hemorrhage during oral anticoagulation therapy. Imaizumi et al. (J Stroke Cerebrovasc Dis, 2013) found that warfarin alone did not increase the incidence of intracerebral hemorrhage in all subjects with CMBs, but subjects with 3 or more deep CMBs did show an increased incidence. Also, a meta-analysis conducted by Lovelock et al. (Stroke, 2010) demonstrated a higher incidence of CMBs in patients with intracerebral hemorrhage receiving warfarin than in patients with intracerebral hemorrhage not receiving antithrombotic therapy. Recently, Orken et al (Clin Neurol Neurosurg, 2013) 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 (p=0.03). However, there has been no study on the progression of CMBs in patients receiving so-called novel oral anticoagulants (NOACs). NOACs, including dabigatran (Hart et al, Stroke 2012), rivaroxaban (Patel et al, N Engl J Med 2011), apixaban (Granger CB et al, N Engl J Med 2011), and edoxaban (Giugliano et al, N Engl J Med 2013), are superior to warfarin in preventing stroke or systemic embolism in patients with NVAF, and have been reported to significantly reduce the incidence of hemorrhagic stroke. Therefore, this study was designed to evaluate and compare the absolute number of CMBs in patients with at least one CMB at baseline, who receive anticoagulant therapy with NOACs and with warfarin. The correlation between CMBs and intracranial hemorrhage, as well as the status of CMBs before commencement of treatment and their progression during treatment, will be evaluated to determine whether there are differences between the two groups.
The feature of this study Japan has a very high availability of MRI facilities, and thus CMBs can be readily evaluated in multiple patients using T2*WI. As of January 1, 2013, the total population of Kanagawa Prefecture was 9.07 million, of whom the elderly (≥65 years) comprised 1.95 million; therefore, a clinical observational study covering this prefecture that revealed a significant difference between NOACs and warfarin should have a substantial impact on drug-prescribing practice. CMBs found on T2*-weighted gradient-echo MRI 1.5 Tesla should be evaluated. The imaging data will be evaluated by the Cerebral Microbleeds Evaluation Committee using the assessment scale of Gregoire et al. under a blinded condition.
Study design This study tests the hypothesis that the incidence of hemorrhagic stroke is lower in patients receiving NOACs than in those receiving warfarin, and this difference reflects the difference in the effects of warfarin and NOACs on the progression of CMBs in patients with at least one CMB. 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. 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. For quality assurance, data validation and registry procedures including any plans for site monitoring and auditing is performed.
Sample Size and Sample Size Justification Orken et al. (Clin Neurol Neurosurg, 2013) suggested that more patients who had CMBs at baseline developed new CMBs (26%) after 2 years, compared with patients (12%) who did not have CMBs at baseline. Therefore, the rate of new CMBs in warfarin-treated patients who had at least one CMB at baseline was assumed to be 13% in 1-year follow-up. Meanwhile, in the ENGAGE AF-TIMI study, the incidence of intracranial hemorrhage among patients receiving edoxaban (one of the NOACs) was about half of that in patients receiving warfarin; the rate of appearance of new CMBs was assumed to be 6.5%. Simulations (10,000 times) indicated that the probability that the rank order of the rate of newly developed CMBs in 1 year would not be reversed between the two groups was 92.7% (power: 19%, two-sided α= 0.05). As this is a pilot study, the number of necessary subjects was estimated to be 100 subjects in 1 group and 200 in 2 groups combined, based on the above results.
Statistical Analysis plan For proportion with new CMBs at month 6 and at month 12, number of new CMBs at months 6 and 12, and location of CMBs, major analyses will be conducted according to the per protocol set (PPS) principle. In addition, for incidence rate of adverse events, major analyses will be conducted according to the intention to treat (ITT) principle. As the primary endpoints analyses (proportion with new CMBs at month 12), the NOACs group and the warfarin group will be compared with respect to total CMBs positive proportion. It' will be also compared between the NOACs group and the warfarin group about the respective secondary endpoints (proportion with new CMBs at month 6, number of new CMBs at months 6 and 12, location of CMBs, incidence rate of adverse events). Proportion of subjects with an increased number of CMBs at month 12 is compared among NOACs. As the need arises, such as the comparison among NOACs, it will be stratified by the factors which are a patient background, the treatment contents and etc., and will be analyzed.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

Diagnosis of NVAF
Diagnosis of cerebral infarction or TIA within 2 weeks after onset
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
Age ≥20 years and ≤85 years
Ability to give valid consent and to provide consent in writing or availability of relatives to provide surrogate consent.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Proportion of subjects with an increased number of CMBs at Month 12 of treatment with NOACs or warfarin
Time frame: 1 year

4 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
Derived from this study: PubMed 26153510Takizawa S, Tanaka F, Nishiyama K, Hasegawa Y, Nagata E, Mizuma A, Yutani S, Nakayama T, Kobayashi H, Yanagimachi N, Okazaki T, Kitagawa K; CMB-NOW Study Investigators. 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. J Stroke Cerebrovasc Dis. 2015 Sep;24(9):2143-8. doi: 10.1016/j.jstrokecerebrovasdis.2015.05.032. Epub 2015 Jul 4.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shunya Takizawa, MD, PhD principal investigator

Tokai University School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Atrial Fibrillation Symptomatic, run by Tokai University at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with an increased number of CMBs at Month 12 of treatment with NOACs or warfarin (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02356432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.