Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study-

Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study- - Anti-inflammatory effects of rivaroxaban versus dabigatran

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009553

Enrollment

200

Registered

2012-12-14

Start date

2013-07-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-valvular atrial fibrillation

Interventions

After baseline assessment of blood examination, patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central regis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with non-valvular atrial fibrillation who have no contraindication for anticoagulantion with a CHADS2-VASc score of 1 or more

Exclusion criteria

Exclusion criteria: (1)stroke or systemic embolism within 6 months before enrollment (2)acute coronary syndromes or peripheral artery disease within 6 months before enrollment (3)acute heart failure (4)severe chronic renal failure (creatinine clearance < 30mL/min.) (5)receiving dual antiplatelet therapy (6)patients with a body weight of 50kg or less (7)uncontrolled hypertention (8)active malignancy (9)patients undergoing surgery within 6 months before enrollment (10)collagen disease (11)infectious disease (12)patients who are planned to undergoing catheter ablation for atrial fibrillation (13)contraindication of rivaroxaban or dabigatran (14)patients who are not allowed to participate in the trial by judgement of the treating physician

Design outcomes

Primary

Measure	Time frame
median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, interleukin-18) between at baseline and 12 months later in each treatment group	—

Secondary

Measure	Time frame
(1)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 (2)frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism) (3)frequency of 12-month major bleeding (defined as ISTH criteria)	—

Measure

Time frame

(1)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 (2)frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism) (3)frequency of 12-month major bleeding (defined as ISTH criteria)

—

Countries

Japan

Contacts

Public ContactKengo Tsukahara

Yokohama City University Medical Center Division of Cardiology

k-tsuka@urahp.yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026