Clinical trial NCT02331602: Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran
Official title: Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
anticoagulation
inflammation
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
Collaborators: name: Yokohama City University
First posted: 2015-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.

Detailed description: Previous study showed that administration of rivaroxaban reduced expression of proinflammatory mediators in apolipoprotein E-deficient mice. However, it is unknown whether the anti-inflammatory markers are decreased in patients with atrial fibrillation receiving novel oral anticoagulants.

Eligibility criteria: Inclusion Criteria:

* non-valvular atrial fibrillation
* a CHADS2-VASc score of 1 or more

Exclusion Criteria:

* contraindication for rivaroxaban or dabigatran
* stroke or systemic embolism, acute coronary syndromes or peripheral artery disease within 6 months before enrollment
* acute heart failure
* severe chronic renal failure (creatinine clearance \< 30mL/min.)
* receiving dual antiplatelet therapy
* patients with a body weight of 50kg or less
* uncontrolled hypertension
* active malignancy, collagen disease, or infectious disease
* patients undergoing surgery within 6 months before enrollment
* patients who are planned to undergoing catheter ablation for atrial fibrillation
* patients who are not allowed to participate in the trial by judgement of the treating physician

Primary outcomes:
measure: median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) between at baseline and 12 months later in each treatment group
timeFrame: 12 months
Secondary outcomes:
measure: change over time of above inflammatory markers during 12 months follow-up period (at baseline, 1 month, 3 months, 6 months, and 12 months later) in each treatment group
timeFrame: 12 months
Other outcomes:
measure: frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism)and frequency of 12-month major bleeding (defined as ISTH criteria)
timeFrame: 12 months
Locations:
city: Ashigaura
country: Japan
facility: Ashigara Kami Hospital
state: Kanagawa
city: Chigasaki
country: Japan
facility: Chigasaki Municipal Hospital
state: Kanagawa
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Fujisawa
country: Japan
facility: Fujisawa Shounandai Hospital
state: Kanagawa
city: Hadano
country: Japan
facility: Hadano Red Cross Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Nagatsuta kousei general hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohama City Southern Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Disease Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Seamen's Insurance Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: International Goodwill Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka City hospital
state: Kanagawa
city: Atami
country: Japan
facility: International University of Health and Welfare Atami Hospital
state: Shizuoka
city: Ohta
country: Japan
facility: Omori Red Cross Hospital
state: Tokyo
Study officials:
affiliation: Yokohama City University Medical Center
name: Kazuo Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References: