Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

NCT02331602 | Unknown Phase 4 DMC

• 1 other identifier: Kimura5656
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; anticoagulation; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (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

  12 months

Other Outcomes (1)

• 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)

  12 months

Study Arms (2)

rivaroxaban

ACTIVE COMPARATOR

Patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.

Drug: Rivaroxaban

dabigatran

ACTIVE COMPARATOR

Patients are assigned to receive dabigatran 150mg twice daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.

Drug: Dabigatran

Interventions

Rivaroxaban DRUG

Patients are assigned to receive rivaroxaban 15mg once daily for 12 months. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.

Also known as: Xarelto

rivaroxaban

Dabigatran DRUG

Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.

Also known as: Pradaxa

dabigatran

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yokohama City University Medical Center: lead
• Yokohama City University: collaborator

Study Sites (16)

Ashigara Kami Hospital

Ashigaura, Kanagawa, 258-0003, Japan

RECRUITING

Chigasaki Municipal Hospital

Chigasaki, Kanagawa, 253-0042, Japan

RECRUITING

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

RECRUITING

Fujisawa Shounandai Hospital

Fujisawa, Kanagawa, 252-0802, Japan

RECRUITING

Hadano Red Cross Hospital

Hadano, Kanagawa, 257-0017, Japan

RECRUITING

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

RECRUITING

Nagatsuta kousei general hospital

Yokohama, Kanagawa, 226-0027, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

Saiseikai Yokohama City Southern Hospital

Yokohama, Kanagawa, 234-8503, Japan

RECRUITING

Kanagawa Cardiovascular and Respiratory Disease Center

Yokohama, Kanagawa, 236-0051, Japan

RECRUITING

Yokohama Seamen's Insurance Hospital

Yokohama, Kanagawa, 240-8585, Japan

RECRUITING

International Goodwill Hospital

Yokohama, Kanagawa, 245-0006, Japan

RECRUITING

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

RECRUITING

Yokosuka City hospital

Yokosuka, Kanagawa, 240-0195, Japan

RECRUITING

International University of Health and Welfare Atami Hospital

Atami, Shizuoka, 413-0012, Japan

RECRUITING

Omori Red Cross Hospital

Ohta, Tokyo, 143-8527, Japan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Inflammation

Interventions

Rivaroxaban; Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kazuo Kimura, MD

  Yokohama City University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kengo Tsukahara, MD

CONTACT

81-45-261-5656; k-tsuka@urahp.yokohama-cu.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Cardiology

Study Record Dates

• First Submitted: January 5, 2014
• First Posted: January 6, 2015
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

JP (16)