Use of Direct Oral Anticoagulants in UK

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119116
• Other study ID #: 19330
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: April 16, 2019

Study information

• Verified date: April 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31336
• Est. completion date: April 16, 2019
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD
• Dabigatran
Oral direct thrombin inhibitors, 75mg and 150mg capsules BID
• Apixaban
Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID

Locations

Country	Name	City	State
United Kingdom	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 years
Primary	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	6 years
Primary	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)	12 months prior to index date
Primary	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	12 months prior to index date
Primary	Previous use of VKA	Warfarin; Other Vitamin K antagonist(s)	Ever prior to index date
Primary	Concurrent co-medication	Anti-coagulants; Aspirin; Clopidogrel; Other	6 years
Primary	Daily dose	DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment	6 years
Primary	Dose posology	DOACs for stroke prevention in NVAF patients including those with renal impairment	6 years
Primary	Naive status and Non-naive status	DOACs for stroke prevention in NVAF patients including those with renal impairment	6 years
Primary	Treatment Duration	DOACs for stroke prevention in NVAF patients including those with renal impairment	6 years
Secondary	Time-trends	Characteristics of first-time use of DOACs in NVAF patients	6 years

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