Use of Direct Oral Anticoagulants in UK

Completed

• Conditions: Stroke
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban; Drug: Dabigatran

• Registration Number: NCT03119116
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-05-15
• Primary Completion: 2017-10-16
• Study Completion: 2019-04-16
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31336

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke Prevention with Rivaroxaban in NVAF Patients	Rivaroxaban (Xarelto, BAY59-7939)	All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period
Stroke Prevention with Apixaban in NVAF Patients	Apixaban	All NVAF patients above 18 years for age prescribed with Apixaban during the study period
Stroke Prevention with Dabigatran in NVAF Patients	Dabigatran	All NVAF patients above 18 years for age prescribed with Dabigatran during the study period

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time-trends	6 years	Characteristics of first-time use of DOACs in NVAF patients

Trial Locations

Locations (1)

Many Locations; 🇬🇧 Multiple Locations, United Kingdom