Use of Direct Oral Anticoagulants in UK
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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
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Condition or disease | Intervention/treatment |
---|---|
Stroke | Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Dabigatran Drug: Apixaban |
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 |

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
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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
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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
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Drug: Apixaban
Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID |
- 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
- Time-trends [ Time Frame: 6 years ]Characteristics of first-time use of DOACs in NVAF patients

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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 |
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.

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
United Kingdom | |
Many Locations | |
Multiple Locations, United Kingdom |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Prevention in NVAF patients |
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 |