NCT02975453

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

December 5, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

November 18, 2016

Last Update Submit

November 3, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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

    At baseline

  • 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

    At 2 years and 6 months or early termination

Secondary Outcomes (10)

  • Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones

    At baseline

  • Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)

    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

  • Occurrence of stroke

    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

  • Occurrence of transient ischemic attack (TIA)

    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

  • Occurrence of systemic embolism

    At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination

  • +5 more secondary outcomes

Study Arms (1)

Rivaroxaban

Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

As prescribed by the treating physician

Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with non-valvular atrial fibrillation who are under rivaroxaban treatment and that attend the Cardiology Units at Spanish hospitals and private clinics

You may qualify if:

  • Adult patients aged 18 years or older.
  • Patients with diagnosis of NVAF.
  • Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent.

You may not qualify if:

  • Patients participating in an investigational program with interventions outside of routine clinical practice.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Spain

Location

Related Publications (1)

  • Rivera-Caravaca JM, Anguita Sanchez M, Sanmartin Fernandez M, Rafols C, Baron-Esquivias G, Arribas Ynsaurriaga F, Freixa-Pamias R, Lekuona Goya I, Vazquez Rodriguez JM, Perez-Cabeza AI, Cosin-Sales J, Urena Montilla I, Alvarez-Vieitez Blanco A, Marin F. Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment. Am J Cardiol. 2023 Sep 15;203:122-127. doi: 10.1016/j.amjcard.2023.06.105. Epub 2023 Jul 22.

    PMID: 37487406BACKGROUND

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 29, 2016

Study Start

December 5, 2016

Primary Completion

March 18, 2020

Study Completion

August 26, 2020

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

ES(1)