check_circleStudy Completed

Stroke

Bayer Identifier:

19330

ClinicalTrials.gov Identifier:

NCT03119116

EudraCT Number:

Not Available

EU CT Number:

Not Available
Use of Direct Oral Anticoagulants in UK

Trial 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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • -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)


  • -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.

Trial summary

Enrollment Goal
31336
Trial Dates
May 2017 - April 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locationsmany locations, United Kingdom

Primary Outcome

  • Demographic Characteristics
    •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
    date_rangeTime Frame:
    6 years
  • Risk factor categories
    •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
    date_rangeTime Frame:
    6 years
  • Previous medical history
    •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)
    date_rangeTime Frame:
    12 months prior to index date
  • Previous medication history
    •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
    date_rangeTime Frame:
    12 months prior to index date
  • Previous use of VKA
    •Warfarin •Other Vitamin K antagonist(s)
    date_rangeTime Frame:
    Ever prior to index date
  • Concurrent co-medication
    •Anti-coagulants •Aspirin •Clopidogrel •Other
    date_rangeTime Frame:
    6 years
  • Daily dose
    DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment
    date_rangeTime Frame:
    6 years
  • Dose posology
    DOACs for stroke prevention in NVAF patients including those with renal impairment
    date_rangeTime Frame:
    6 years
  • Naive status and Non-naive status
    DOACs for stroke prevention in NVAF patients including those with renal impairment
    date_rangeTime Frame:
    6 years
  • Treatment Duration
    DOACs for stroke prevention in NVAF patients including those with renal impairment
    date_rangeTime Frame:
    6 years

Secondary Outcome

  • Time-trends
    Characteristics of first-time use of DOACs in NVAF patients
    date_rangeTime Frame:
    6 years

Trial design

Pattern of use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation patients in UK general practices
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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