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Trial record 59 of 156 for:    warfarin AND Vitamin K

Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice (SiERRA UK)

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ClinicalTrials.gov Identifier: NCT03847181
Recruitment Status : Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bayer

Brief Summary:
This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as treatment for Stroke Prevention in Atrial Fibrillation (SPAF). Purpose of the study is to learn more about the safety and how well the drugs rivaroxaban, apixaban and warfarin work in patients appropriately and inappropriately receiving standard and reduced doses of each drug for reducing the risk of stroke in atrial fibrillation. Real world data from routine general practice stored in the primary care database in the UK, The Health Improvement Network (THIN), will be used for investigation.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Apixaban (Eliquis) Drug: Warfarin

Detailed Description:
Primary objectives are to assess the safety and effectiveness of rivaroxaban, apixaban and warfarin based on the risk of intracranial hemorrhage and hemorrhagic strokes (safety) and ischemic stroke, systemic embolism and myocardial infarction (effectiveness). Secondary objectives comprise the assessment of the mentioned risks in subpopulations of patients with renal impairment or diabetes, mortality rates, and drug utilisation as well as patient characteristics before and after the first intracranial hemorrhage or ischemic stroke.

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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NVAF-patients_1
Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban at a dose of 15 or 20 mg once daily
Other Name: Non-Vitamin K Oral Anticoagulant (NOAC)

NVAF-patients_2
Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.
Drug: Apixaban (Eliquis)
Apixaban at a dose of 2.5 or 5 mg twice daily
Other Name: Non-Vitamin K Oral Anticoagulant (NOAC)

NVAF-patients_3
Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.
Drug: Warfarin
Warfarin dose as prescribed by medical practitioner
Other Name: Vitamin K Antagonist




Primary Outcome Measures :
  1. Risk of intracranial hemorrhage [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.

  2. Risk of ischemic events [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.


Secondary Outcome Measures :
  1. Risk of intracranial hemorrhage in NVAF-patients with renal impairment [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.

  2. Risk of ischemic events in NVAF-patients with renal impairment [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Ischemic events include ischaemic stroke /systemic embolism and myocardial infarction.

  3. Risk of intracranial hemorrhage in NVAF-patients with diabetes [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.

  4. Risk of ischemic events in NVAF-patients with diabetes [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Ischemic events include ischaemic stroke /systemic embolism and myocardial infarction.

  5. All-cause mortality [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Rate of deaths from all causes.

  6. Drug utilisation [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.

  7. Drug utilisation after first intracranial hemorrhage or ischemic stroke [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.

  8. Patient characteristics [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.

  9. Patient characteristics after first intracranial hemorrhage or ischemic stroke [ Time Frame: Retrospective analysis of data from 2012 to 2017 ]
    Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UK population sample representative for age, sex and geographic distribution
Criteria

Inclusion Criteria:

  • Patients with non-valvular atrial fibrillation
  • New users of rivaroxaban, apixaban or warfarin
  • At least one year enrollment with the general practice (GP)
  • One year since first health contact recorded in THIN prior to the first prescription of a study drug

Exclusion Criteria:

  • Patients with other recent indications of oral anticoagulant initiation
  • Individuals on more than one oral anticoagulant on the start date
  • Users of rivaroxaban apart from 15 / 20 mg daily dose
  • Users of apixaban apart from 5 / 10 mg daily dose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847181


Locations
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United Kingdom
Many facilities
Many Sites, United Kingdom
Sponsors and Collaborators
Bayer
Janssen, LP

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03847181     History of Changes
Other Study ID Numbers: 20343
EUPAS28234 ( Other Identifier: ENCePP )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Oral anticoagulants
Under-dosing
Stroke prevention in atrial fibrillation
Safety
Effectiveness
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action