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StrokeNCT03119116

Use of Direct Oral Anticoagulants in UK

An observational study of Stroke, run by Bayer at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939), Dabigatran and Apixaban
Type of treatment
Pill or oral medicine
How many people
31,336 participants
Where
1 siteUnited Kingdom
Study dates
15 May 2017to 16 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Population based on primary care databases representative of the UK population.

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Many Locations

    Multiple Locations

Other trials in United Kingdom

About this study

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

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.

Conditions
Stroke
Being tested
Rivaroxaban (Xarelto, BAY59-7939), Dabigatran, Apixaban
Keywords
Stroke Prevention in NVAF patients
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

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

  • DabigatranDrug

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

  • ApixabanDrug

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

Study groups in NCT03119116
Study groupRoleWhat they receive
Stroke Prevention with Rivaroxaban in NVAF PatientsAll NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Stroke Prevention with Dabigatran in NVAF PatientsAll NVAF patients above 18 years for age prescribed with Dabigatran during the study period
Receives: Drug: Dabigatran
Stroke Prevention with Apixaban in NVAF PatientsAll NVAF patients above 18 years for age prescribed with Apixaban during the study period
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 years

  2. 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

    Measured: 6 years

  3. 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)

    Measured: 12 months prior to index date

  4. 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

    Measured: 12 months prior to index date

  5. Previous use of VKA

    • Warfarin
    • Other Vitamin K antagonist(s)

    Measured: Ever prior to index date

  6. Concurrent co-medication

    • Anti-coagulants
    • Aspirin
    • Clopidogrel
    • Other

    Measured: 6 years

  7. Daily dose

    DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment

    Measured: 6 years

  8. Dose posology

    DOACs for stroke prevention in NVAF patients including those with renal impairment

    Measured: 6 years

  9. Naive status and Non-naive status

    DOACs for stroke prevention in NVAF patients including those with renal impairment

    Measured: 6 years

  10. Treatment Duration

    DOACs for stroke prevention in NVAF patients including those with renal impairment

    Measured: 6 years

Secondary outcomes (1)

  1. Time-trends

    Characteristics of first-time use of DOACs in NVAF patients

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start15 May 2017
  3. Primary completion16 Oct 2017
  4. Study completion16 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
31,336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119116
Sponsor's protocol ID
19330
Status last verified
Apr 2020
First submitted
13 Apr 2017
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Bayer at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic Characteristics (time frame: 6 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03119116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.

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