RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Japan Cardiovascular Research Foundation
Sponsor:
Information provided by (Responsible Party):
Kazuo Minematsu, Japan Cardiovascular Research Foundation
ClinicalTrials.gov Identifier:
NCT02129920
First received: May 1, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

Early recurrence of cardioembolic stroke in patients with atrial fibrillation is common, reaching approximately 6% within 30 days after initial stroke. Therefore, it is preferable to provide early anticoagulation for cardioembolic stroke. However, early anticoagulation may increase the risk of hemorrhagic transformation of cerebral infarcts. It is difficult to decide the timing of initiation for anticoagulant therapy in stroke patients with non-valvular atrial fibrillation (NVAF). In 2013 the European Heart Rhythm Association presented the practical guides for oral anticoagulants in NVAF patients, which recommend that the optimal time to start anticoagulant therapy should be determined according to the stroke severity. However, this recommendation is principally an experts' opinion and is not suitable in the clinical practice in Japan.

RELAXED, a multicenter observational study is planned to evaluate the efficacy and safety of an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic stroke patients with NVAF in consideration of the infarct size, timing of initiation for rivaroxaban medication, and other patient characteristics, and thereby to determine the optimal timing of the initiation during acute ischemic stroke. The consecutive acute ischemic stroke / transient ischemic attack (TIA) patients with NVAF who are treated with rivaroxaban will be enrolled. The infarction size at 0-48 hours after stroke onset will be measured by the diffusion weighted image (DWI) MRI. The primary efficacy endpoint is recurrent ischemic stroke within 3 months. The primary safety endpoint is major bleedings within 3 months. The optimal timing to initiate rivaroxaban during acute ischemic stroke is determined by analysis of co-relation between primary endpoints and the infarct size / time to initiate rivaroxaban.


Condition Intervention
Stroke, Acute
Atrial Fibrillation
Other: This is an observational study

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Recurrent Embolism Lessened by Rivaroxaban, an Anti-Xa Agent of Early Dosing for Acute Ischemic Stroke and Transient Ischemic Attack With Atrial Fibrillation Study (RELAXED)

Resource links provided by NLM:


Further study details as provided by Japan Cardiovascular Research Foundation:

Primary Outcome Measures:
  • Recurrent ischemic stroke and major bleeding [ Time Frame: 3 monhths ] [ Designated as safety issue: Yes ]

    The optimal timing to start treatment with rivaroxaban of the initiation for during acute ischemic stroke are determined by analysis of co-relation between primary endpoints including recurrent ischemic stroke / major bleeding, and the cerebral infarction size / time to start treatment with rivaroxaban.

    Major bleeding according to the criteria by the International Society of Thrombosis and Haemostasis (ISTH)



Secondary Outcome Measures:
  • ischemic stroke and transient ischemic attack [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Composite cardiovascular events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The composite cardiovascular events are included ischemic stroke, TIA, systemic embolism, acute coronary syndrome, deep vein thrombosis, pulmonary embolism, other ischemic disease, revascularization, total death, cardiovascular death

  • Any bleeding events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Intracranial hemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Hemorrhagic transformation of cerebral infarcts [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Adverse event [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Recurrence of ischemic stroke and major bleeding according to whether or not heparin is administered [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Recurrence of ischemic stroke and major bleeding according to whether rivaroxaban is administered in the morning or evening [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Duration of hospitalization [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Safety and efficacy of rivaroxaban administration via tube or by crush tablet [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Definite clinical data on patients developing recurrent ischemic stroke or intracranial hemorrhage during rivaroxaban medication [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Medical expenditures using a model [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: February 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NVAF, acute ischemic stroke/TIA
Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban
Other: This is an observational study
Other Name: This is an observational, not intervention, study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation and treated with rivaroxaban

Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
  • Having non-valvular atrial fibrillation
  • Visiting the clinic/hospital within 48 hours of the onset of acute ischemic stroke or TIA
  • Identification of an infarct in the middle cerebral artery (MCA) territory (symptoms ascribable to ischemia in the MCA territory in TIA patients)
  • Initiation of treatment with rivaroxaban within 30 days of the onset of acute ischemic stroke or TIA
  • Written informed consent by patients

Exclusion Criteria:

  • hypersensitivity to rivaroxaban 2) Active bleeding (clinically significant hemorrhage) including gastrointestinal hemorrhage
  • liver disease complicated with coagulation disorder
  • liver disorder corresponding to Child-Pugh Class B or C
  • renal failure (creatinine clearance: <15 mL/minute)
  • poorly controlled hypertension (higher than 180/100)
  • Woman who are or are likely to be pregnant
  • Ongoing treatment with HIV protease inhibitors including ritonavir, atazanavir and indinavir
  • Ongoing treatment with itraconazole, voriconazole and ketoconazole
  • Active bacterial endocarditis
  • Patients considered by the investigator to be unsuitable for participating in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129920

Contacts
Contact: Satoko Matsumoto +81-6-6872-0010 relaxed@jcvrf.jp
Contact: Minoru Ido +81-6-4807-3015 prj-relaxed_cont@eps.co.jp

Locations
Japan
Japan Cardiovascular Research Foundation Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Satoko Matsumoto    +81-6-6872-0010    relaxed@jcvrf.jp   
Contact: Minoru Ido    +81-6-4807-3015    prj-relaxed_cont@eps.co.jp   
Sponsors and Collaborators
Japan Cardiovascular Research Foundation
Investigators
Principal Investigator: Kazuo Minematsu, M.D. Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center
  More Information

No publications provided

Responsible Party: Kazuo Minematsu, M.D., Japan Cardiovascular Research Foundation
ClinicalTrials.gov Identifier: NCT02129920     History of Changes
Other Study ID Numbers: M25-113
Study First Received: May 1, 2014
Last Updated: May 1, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Japan Cardiovascular Research Foundation:
Stroke
Cerebral Infarction
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Anticoagulants
Hematologic Agents
Therapeutic Uses

Additional relevant MeSH terms:
Atrial Fibrillation
Ischemic Attack, Transient
Embolism
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Embolism and Thrombosis
Brain Infarction
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014