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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025392
Receipt No. R000029222
Scientific Title Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis
Date of disclosure of the study information 2017/02/01
Last modified on 2018/12/25

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Basic information
Public title Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis
Acronym ATIS-NVAF study
Scientific Title Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis
Scientific Title:Acronym ATIS-NVAF study
Region
Japan

Condition
Condition Ischemic Stroke
Atrial Fibrillation
Atherothrombosis
Classification by specialty
Medicine in general Cardiology Neurology
Geriatrics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Purpose of the study is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Composite endpoint of ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization) and major bleeding defined by the International Society on Thrombosis and Haemostasis(ISTH) criteria within 2 years after randomization
Key secondary outcomes Incidences of following events within 2years after randomization:

* All-cause mortality
* Ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization)
* All ischemic cardiovascular events including transient ischemia (cardiovascular death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina pectoris, systemic embolism, progression of symptomatic peripheral artery disease, ischemic events requiring urgent revascularization)
* Ischemic stroke
* Myocardial infarction and cardiovascular death
* ISTH major bleeding
* ISTH major bleeding and clinically relevant non-major bleeding
* Intracranial hemorrhage

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dual-therapy group: single anticoagulant drug (warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban) and single antiplatelet drug (aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol)

The dosage is determined according to each drug's package insert in Japan.

In patients treated with warfarin, the target INR range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
Interventions/Control_2 Single-therapy group: single anticoagulant drug (warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban)

The dosage is determined according to each drug's package insert in Japan.

In patients treated with warfarin, the target INR range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days from the onset of symptoms
2. Age: 20-90 years.
3. Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant
4. Patients who have one of the following atherothrombotic diseases
a) A past history of ischemic heart disease (myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention(PCI)
b) A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting)
c) Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA))
d) Intracranial artery stenosis (=>50% stenosis of the diameter of a major intracranial artery: intracranial internal carotid artery, anterior cerebral artery (ACA)-A1 and A2, middle cerebral artery (MCA)-M1 and M2, posterior cerebral artery (PCA)-P1 and P2, vertebral artery, and basilar artery; a history of intracranial stent placement or intracranial bypass surgery)
e) A past history of atherothrombotic brain infarction, lacunar infarction, or branch atheromatous disease
5. Patients who can walk independently (modified Rankin Scale score =<3)
6. Patients who can take oral medications
7. Patients who can receive follow-up survey
8. Provision of written informed consent either directly or by a suitable surrogate
Key exclusion criteria 1. Patients with a history of myocardial infarction or acute coronary syndrome within the past 12 months
2. Patients who underwent PCI with drug-eluting stents within the past 12 months or PCI with bare-metal stents within the past 3 months
3. Patients who underwent carotid artery stent placement, intracranial stent placement, or lower extremity stent placement within the past 3 months
4. History of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the past 6 months
5. Hemorrhagic diathesis or blood coagulation disorders
6. Platelet counts <100,000 /mm3 at enrollment.
7. Severe anemia (hemoglobin <7 g/dL)
8. Severe renal failure (creatinine clearance =<15 mL/min) or who are undergoing chronic hemodialysis.
9. Severe liver dysfunction (Grade B or C of the Child-Pugh classification)
10. Patients who are unable to walk independently (modified Rankin Scale score =>4)
11. Pregnant or possibly pregnant women
12. Active cancer
13. Expectation of survival less than 2 years
14. Anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during the follow-up period
15. Planned revascularization procedure during the follow-up period
16. Patients who are enrolled in other trials
17. Patients judged as inappropriate for this study by investigators
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi YAMAGAMI
Organization National Cerebral and Cardiovascular Center
Division name Division of Cerebrovascular Medicine and Neurology
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL +81-6-6833-5012
Email yamagami-brain@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanta TANAKA
Organization National Cerebral and Cardiovascular Center
Division name Division of Stroke Care Unit
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL +81-6-6833-5012
Homepage URL https://www.atis-nvaf.net
Email tanaka1983kanta@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program (JRISTA)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Network for Clinical Stroke Trials (NeCST)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 Day

Related information
URL releasing protocol https://www.atis-nvaf.net/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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