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Trial record 9 of 156 for:    warfarin AND Vitamin K

Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)

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ClinicalTrials.gov Identifier: NCT03490994
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE March 11, 2018
First Posted Date  ICMJE April 6, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE April 10, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2018)
the change of high sensitive troponin [ Time Frame: Baseline to 72 hours ]
The maximum hsTn value change from baseline to during hospitalization
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03490994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2018)
  • 1) the change of hish sensitive troponin [ Time Frame: 1) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge ]
    1) The change from baseline in hsTn on Day2, day4, day7 (or discharge), and follow-up visits at 1 month, 6 months
  • 2) the change of D-dimer [ Time Frame: 2) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge ]
    2) D-dimer change from baseline during hospitalization (day2, day4, day7 or discharge) & follow-up visits at 1, 6 months
  • 3) the change of NT-proBNP [ Time Frame: 3) On admission, hospital day #7 or discharge, 1 month/6month after discharge ]
    3) TAT complex, PAI-1, hsCRP, NT-proBNP, sST2, galectin-3, cystatin C, NGAL, NAG change from baseline to day7 or discharge & 1,6 months after discharge
  • 4) bleeding event [ Time Frame: 4) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/3month/6month after discharge ]
    4) Incidence proportion and rate of major/minor bleeding during the study
  • 5) hospital stay [ Time Frame: 5) The duration of hospital stay, average 7 days ]
    5) Length of hospital stay
  • 6) all-cause mortality [ Time Frame: 6) 6 months after hospitalization ]
    6) Incidence proportion of in-hospital all-cause death cases
  • 7) all-cause hospitalization & mortality [ Time Frame: 7) 6 months after hospitalization ]
    7) Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)
Official Title  ICMJE Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)
Brief Summary

Vitamin K antagonists (VKAs) are used to reduce the risk of stroke (cerebral vascular dysfunction) in AF patients. However, VKAs interact with drugs/food and the drug level is influenced by worsening of renal function, liver congestion or hemodynamic alterations in acute decompensated heart failure (ADHF). New oral anticoagulants (rivaroxaban, apixaban, dabigatran) are alternatives to VKA, such as warfarin. In post hoc analysis of ROCKET AF trial, 63.7% patients had HF and treatment-related outcomes were similar in patients with and without HF (Circulation HF. 2013; 6:740-7). So rivaroxaban 20 mg daily (or 15 mg daily in patients with creatinine clearance 30-49 mL/min) was safe in nonvalvular AF patients with HF. However, the clinical effect and safety of rivaroxaban were largely unknown in acute decompensated heart failure (ADHF) patients with atrial fibrillation (AF).

ROAD HF-AF is the exploratory study to assess the change of surrogate markers (hsTn, d-dimer) when treated with rivaroxaban vs. warfarin and to strengthen the basis for future biomarker-based therapy in ADHF patients

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
warfarin vs. rivaroxaban
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Heart Failure
Intervention  ICMJE
  • Drug: Rivaroxaban
    Rivaroxaban 20mg qd (15mg qd when CrCl 30-49 ml/min using creatinine-based CKD-EPI equations) for 6 months
  • Drug: Warfarin + LMWH
    dose-adjusted warfarin (target INR 2-3) for 6 months + LMWH (enoxaparin 1 mg/kg q12h for a few days until INR target achieved) if indicated
Study Arms  ICMJE
  • Experimental: Rivaroxaban
    Rivaroxaban
    Intervention: Drug: Rivaroxaban
  • Active Comparator: Warfarin
    warfarin + enoxaparin
    Intervention: Drug: Warfarin + LMWH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:Hospitalized patients with a primary diagnosis of ADHF with AF One of the following criteria and LVEF ≤ 40% (at least 1 year before admission or admission)

  1. dyspnea at rest
  2. tachypnea; a respiratory rate > 20/min
  3. rales
  4. pulmonary edema on chest X-ray

Exclusion Criteria:

  1. History of increased bleeding risk (like ROCKET AF exclusion criteria)
  2. Contraindication to anti-coagulation therapy
  3. ACS diagnosis
  4. Hospitalization plan for PCI, coronary artery bypass graft surgery, other cardiac invasive interventions (e.g. catheter ablation, pacemaker, CRT, ICD implantation)
  5. Currently on dual anti-platelet therapy (aspirin + ADP receptor antagonist) or single antiplatelet therapy with a novel AP (e.g. Ticagrelor, Prasugrel)
  6. Cardiogenic shock (systolic blood pressure, SBP, < 80 mmHg)
  7. Patients with CrCl < 30 ml/min using creatinine-based CKD-EPI equations
  8. Elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis
  9. Uncontrolled hypertension (SBP > 180 mmHg)
  10. Allergy, adverse drug reaction, hypersensitivity to rivaroxaban or warfarin
  11. Life expectancy < 6 months (e.g. metastatic malignancy)
  12. Pregnancy, or women of childbearing age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seok-Min Kang, MD 82-2-2228-8450 smkang@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03490994
Other Study ID Numbers  ICMJE 4-2017-0776
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP