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Use of Direct Oral Anticoagulants in UK

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Bayer
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT03119116
First received: April 13, 2017
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. It is important to prescribe the correct dose of blood thinners to the right patients to ensure the treatment works however avoiding complications. In the recent years, new blood thinners have been available; they require less laboratory tests and fewer visits to a doctor compared to older therapies. This study will look at how the general practitioners in the UK prescribe blood thinners according to the instructions given by the product manufacturer. We will use primary care data that is routinely collected by the general practitioners about their patients but without any possibility to identify individual patients. The results will help us to understand the magnitude of deviation from instructions in order to ensure that the patients benefit from the treatment.

Condition Intervention
Stroke
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Dabigatran
Drug: Apixaban

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Demographic Characteristics [ Time Frame: 6 years ]
    • Age
    • Sex
    • Smoking status (previous 6 months)
    • Body mass index (previous 6 months)
    • Blood pressure history (previous 12 months)
    • Number of patients that are naïve vs non-naïve For non-naïve: type and duration of anticoagulant used before index date

  • Risk factor categories [ Time Frame: 6 years ]
    • C(Congestive heart failure) H(Hypertension)A(Age)D(Diabetes Mellitus)S2(Prior Stroke or TIA) score
    • C(Congestive heart failure) H(Hypertension)A2(Age ≥75 years)D(Diabetes Mellitus)S2 V(Vascular disease)A(Age 65-74 years)SC(Sex category)
    • H(Hypertension)A(Abnormal renal and liver function)S(Stroke)B(Bleeding)L(Labile INRs)E(Elderly)D(Drugs or alcohol) score
    • INR(International Normalized Ratio) measurement

  • Previous medical history [ Time Frame: 12 months prior to index date ]
    • Acute MI(Myocardial Infarction)
    • Stroke or TIA(Transient Ischemic Attack)
    • Systemic peripheral arterial embolism
    • Coronary artery disease
    • Congestive heart disease
    • Hypertension
    • Diabetes Renal disease (eGFR) or ACR (Albumin/Creatinine Ratio)

  • Previous medication history [ Time Frame: 12 months prior to index date ]
    • Anti-arrhythmics
    • Statins
    • Anti-platelets
    • Beta-blockers
    • ACE(Angiotensin-Converting-Enzyme) inhibitors
    • Anti-diabetic agents
    • Non-steroidal anti-inflammatory drugs (NSAIDs)
    • Antacids
    • Histamine receptor antagonists
    • Proton pump inhibitors (PPIs)
    • Disease-modifying anti-rheumatic drugs (DMARDs)
    • Antidepressants
    • Antipsychotic agents
    • Oral contraceptives
    • Hormone replacement therapy (HRT)
    • Strong inhibitors of Cytochrome P450 or P-GP
    • Strong inducers of CYP3A4

  • Previous use of VKA [ Time Frame: Ever prior to index date ]
    • Warfarin
    • Other Vitamin K antagonist(s)

  • Concurrent co-medication [ Time Frame: 6 years ]
    • Anti-coagulants
    • Aspirin
    • Clopidogrel
    • Other

  • Daily dose [ Time Frame: 6 years ]
    DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment

  • Dose posology [ Time Frame: 6 years ]
    DOACs for stroke prevention in NVAF patients including those with renal impairment

  • Naive status and Non-naive status [ Time Frame: 6 years ]
    DOACs for stroke prevention in NVAF patients including those with renal impairment

  • Treatment Duration [ Time Frame: 6 years ]
    DOACs for stroke prevention in NVAF patients including those with renal impairment


Secondary Outcome Measures:
  • Time-trends [ Time Frame: 6 years ]
    Characteristics of first-time use of DOACs in NVAF patients


Estimated Enrollment: 3000
Anticipated Study Start Date: April 17, 2017
Estimated Study Completion Date: May 30, 2017
Estimated Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stroke Prevention with Rivaroxaban in NVAF Patients
All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD
Stroke Prevention with Dabigatran in NVAF Patients
All NVAF patients above 18 years for age prescribed with Dabigatran during the study period
Drug: Dabigatran
Oral direct thrombin inhibitors, 75mg and 150mg capsules BID
Stroke Prevention with Apixaban in NVAF Patients
All NVAF patients above 18 years for age prescribed with Apixaban during the study period
Drug: Apixaban
Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population based on primary care databases representative of the UK population.
Criteria

Inclusion Criteria:

  • All patients aged >= 18 years with at least one year of enrollment with the primary care practice and one year since first health contact recorded in the database THIN(The Health Improvement Network) or CPRD(Clinical Practice Research Datalink) prior to index prescription date will be included.
  • Patients with first prescription of DOACs (rivaroxaban, dabigatran, apixaban) during the study period.
  • Diagnosis NVAF (any time prior index date or within the 2 weeks after the index date)

Exclusion Criteria:

  • Patients having the history of valvular replacement or mitral stenosis (prior to index date or 2 weeks after index-date)
  • Patients who have any record of being prescribed their index drug prior to the enrolment period or who qualify as members of more than one cohort on the same day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03119116

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
United Kingdom
Completed
Many Locations, United Kingdom
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
  More Information

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03119116     History of Changes
Other Study ID Numbers: 19330
Study First Received: April 13, 2017
Last Updated: April 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Stroke Prevention in NVAF patients

Additional relevant MeSH terms:
Apixaban
Factor Xa Inhibitors
Rivaroxaban
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 24, 2017