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Completed

NCT Number: NCT03119116

Use of Direct Oral Anticoagulants in UK

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD

dabigatran

Drug

Oral direct thrombin inhibitors, 75mg and 150mg capsules BID

Apixaban

Drug

Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID

Primary outcomes

  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 outcomes

  1. Time-trends

    Time frame: 6 years

    Characteristics of first-time use of DOACs in NVAF patients

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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