check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18884

ClinicalTrials.gov Identifier:

NCT02975453

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study of major cardiovascular events in patients with nonvalvular atrial fibrillation treated with Rivaroxaban

Trial purpose

Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Adult patients aged 18 years or older.
    - Patients with diagnosis of NVAF.
    - Patients treated with rivaroxaban from at least six months prior to the study inclusion.
    - Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent.


  • - Patients participating in an investigational program with interventions outside of routine clinical practice.
    - Patients who initiate treatment with rivaroxaban after the start of the study inclusion period.
    - Prosthetic heart valves or the presence of any severe valvulopathies.
    - Patients with severe cognitive impairment.
    - Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus) or systemic autoimmune diseases.
    - Patients with active cancer.
    - Patients with liver insufficiency (eg. cirrhosis).

Trial summary

Enrollment Goal
1481
Trial Dates
December 2016 - August 2020
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • 2MACE score
    MACE: Major adverse cardiovascular events. 2MACE: History of Myocardial infarction/ Cardiac revascularization and Metabolic Syndrome, Age >75 years, Congestive heart failure (ejection fraction <40%), Thrombo-Embolism
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Occurrence of MACE to evaluate the performance of the 2MACE index
    Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death
    date_rangeTime Frame:
    At 2 years and 6 months or early termination
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones
    Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)
    date_rangeTime Frame:
    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
    enhanced_encryption
    Safety Issue:
    Yes
  • Occurrence of stroke
    date_rangeTime Frame:
    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
    enhanced_encryption
    Safety Issue:
    Yes
  • Occurrence of transient ischemic attack (TIA)
    date_rangeTime Frame:
    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
    enhanced_encryption
    Safety Issue:
    Yes
  • Occurrence of systemic embolism
    date_rangeTime Frame:
    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
    enhanced_encryption
    Safety Issue:
    Yes
  • Thromboembolic risk based on the CHADS2 score
    CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Thromboembolic risk based on the CHA2DS2-VASC
    CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Number of MACEs occurring during the study
    date_rangeTime Frame:
    At 1 year, at 2 years, at 2 years and 6 months or early termination
    enhanced_encryption
    Safety Issue:
    No
  • Patients' profile
    Baseline patients' profile defined by: sociodemographic data, anthropometric data, previous relevant medical history, cardiac medical history distinct to atrial fibrillation, comorbidities (renal failure, left ventricular dysfunction, hypertension, thyroid dysfunction, liver failure, alcoholism)
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No

Trial design

Study of risk factors of major cardiovascular events in patients with nonvalvular atrial fibrillation treated with a direct oral anticoagulant (Rivaroxaban)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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