RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke

NCT02129920 | Unknown DMC

• 1 other identifier: M25-113
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute; Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recurrent ischemic stroke and major bleeding

  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)

  3 monhths

Secondary Outcomes (12)

• ischemic stroke and transient ischemic attack

  3 months

• Composite cardiovascular events

  3 months

• Any bleeding events

  3 months

• Intracranial hemorrhage

  3 months

• Hemorrhagic transformation of cerebral infarcts

  3 months

Study Arms (1)

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

Interventions

This is an observational study OTHER

Also known as: This is an observational, not intervention, study.

NVAF, acute ischemic stroke/TIA

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Cardiovascular Research Foundation: lead

Study Sites (1)

Japan Cardiovascular Research Foundation

Suita, Osaka, 565-8565, Japan

RECRUITING

Related Publications (2)

• Koge J, Yamagami H, Toyoda K, Yasaka M, Hirano T, Hamasaki T, Nagao T, Yoshimura S, Fujishige M, Tempaku A, Uchiyama S, Mori E, Koga M, Minematsu K. Early initiation of rivaroxaban after reperfusion therapy for stroke patients with nonvalvular atrial fibrillation. PLoS One. 2022 Apr 6;17(4):e0264760. doi: 10.1371/journal.pone.0264760. eCollection 2022.

  PMID: 35385480 DERIVED

• Yasaka M, Minematsu K, Toyoda K, Yamagami H, Yoshimura S, Nagao T, Mori E, Hirano T, Hamasaki T, Yamaguchi T. Design and Rationale of the RELAXED (Recurrent Embolism Lessened by rivaroxaban, an Anti-Xa agent, of Early Dosing for acute ischemic stroke and transient ischemic attack with atrial fibrillation) Study. J Stroke Cerebrovasc Dis. 2016 Jun;25(6):1342-8. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.035. Epub 2016 Mar 14.

  PMID: 26987488 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation; Cerebral Infarction; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Infarction; Brain Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Study Officials

• Kazuo Minematsu, M.D.

  Japan Cardiovascular Research Foundation, and National Cerebral and Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satoko Matsumoto

CONTACT

+81-6-6872-0010; relaxed@jcvrf.jp

Minoru Ido

CONTACT

+81-6-4807-3015; prj-relaxed_cont@eps.co.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 2, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 2, 2014

Record last verified: 2014-04

Locations

JP (1)