Use of Direct Oral Anticoagulants in UK

NCT03119116 | Completed

• 1 other identifier: 19330
• Study Type: observational
• Target: 31,336
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke Prevention in NVAF patients

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• Previous use of VKA

  * Warfarin * Other Vitamin K antagonist(s)

  Ever prior to index date

• Concurrent co-medication

  * Anti-coagulants * Aspirin * Clopidogrel * Other

  6 years

• Daily dose

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

  6 years

• Dose posology

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

  6 years

• Naive status and Non-naive status

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

  6 years

• Treatment Duration

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

  6 years

Secondary Outcomes (1)

• Time-trends

  6 years

Study Arms (3)

Stroke Prevention with Rivaroxaban in NVAF Patients

All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Stroke Prevention with Dabigatran in NVAF Patients

All NVAF patients above 18 years for age prescribed with Dabigatran during the study period

Drug: Dabigatran

Stroke Prevention with Apixaban in NVAF Patients

All NVAF patients above 18 years for age prescribed with Apixaban during the study period

Drug: Apixaban

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

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

Stroke Prevention with Rivaroxaban in NVAF Patients

Dabigatran DRUG

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

Stroke Prevention with Dabigatran in NVAF Patients

Apixaban DRUG

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

Stroke Prevention with Apixaban in NVAF Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Many Locations

Multiple Locations, United Kingdom

Location

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Stroke

Interventions

Rivaroxaban; Dabigatran; apixaban

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: May 15, 2017
• Primary Completion: October 16, 2017
• Study Completion: April 16, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

GB (1)