Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation

NCT02147444 | Unknown DMC

• 2 other identifiers: EXPAND studyUMIN000009376
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.

Conditions

Non-valvular Atrial Fibrillation

Keywords

Rivaroxaban; Non-valvular atrial fibrillation; NOAC; Xa inhibitor

Outcome Measures

Primary Outcomes (2)

• Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism

  Primary efficacy endpoint

  up to March/2016

• Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)

  Primary safety endpoint

  up to March/2016

Secondary Outcomes (11)

• Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death

  up to March/2016

• Symptomatic ischemic stroke

  up to March/2016

• Symptomatic hemorrhagic stroke

  up to March/2016

• Systemic embolism

  up to March/2016

• Acute myocardial infarction/unstable angina pectoris

  up to March/2016

Study Arms (1)

Non-valvular atrial fibrillation

* Patients diagnosed with non-valvular atrial fibrillation * Patients who are treated or will be treated with rivaroxaban

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)

You may qualify if:

• Patients who meet all the criteria below
• Patients aged over 20 years
• Patients diagnosed with non-valvular atrial fibrillation
• Patients who are treated or will be treated with rivaroxaban
• Patients from whom written informed consent has been obtained

You may not qualify if:

• Patients who meet any of the criteria below
• The following patients in whom rivaroxaban is contraindicated for use
• Patients with a history of allergies to the ingredients contained in this drug
• Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
• Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
• Patients having renal failure (creatinine clearance: \<15 mL/min)
• Women who are or are likely to be pregnant
• Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
• Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))

Sponsors & Collaborators

• Tohoku University: lead

Study Sites (1)

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Sendai, Miyagi, 980-6574, Japan

RECRUITING

Related Links

• EXPAND study home page

Study Officials

• Hiroaki Shimokawa, MD, PhD

  Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

  STUDY CHAIR

Central Study Contacts

Koji Fukuda, M.D., Ph. D

CONTACT

+81-22-717-7153; fukuda@cardio.med.tohoku.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Department of Cardiovascular Medicine

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 26, 2014
• Study Start: November 1, 2012
• Primary Completion: June 1, 2016
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

JP (1)