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Use of Direct Oral Anticoagulants in UK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119116
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment
Stroke Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Dabigatran Drug: Apixaban

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Study Type : Observational
Actual Enrollment : 31336 participants
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
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : April 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

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

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

  7. 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

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

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

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


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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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
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.

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): NCT03119116


Locations
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United Kingdom
Many Locations
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03119116    
Other Study ID Numbers: 19330
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
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:
Stroke Prevention in NVAF patients
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Apixaban
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants