check_circleStudy Completed
Stroke
Bayer Identifier:
19330
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Use of Direct Oral Anticoagulants in UK
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
31336Trial Dates
May 2017 - April 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | many locations | many locations, United Kingdom |
Primary Outcome
- 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 datedate_rangeTime Frame: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) measurementdate_rangeTime Frame: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)date_rangeTime Frame: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 CYP3A4date_rangeTime Frame:12 months prior to index date
- Previous use of VKA•Warfarin •Other Vitamin K antagonist(s)date_rangeTime Frame:Ever prior to index date
- Concurrent co-medication•Anti-coagulants •Aspirin •Clopidogrel •Otherdate_rangeTime Frame:6 years
- Daily doseDOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairmentdate_rangeTime Frame:6 years
- Dose posologyDOACs for stroke prevention in NVAF patients including those with renal impairmentdate_rangeTime Frame:6 years
- Naive status and Non-naive statusDOACs for stroke prevention in NVAF patients including those with renal impairmentdate_rangeTime Frame:6 years
- Treatment DurationDOACs for stroke prevention in NVAF patients including those with renal impairmentdate_rangeTime Frame:6 years
Secondary Outcome
- Time-trendsCharacteristics of first-time use of DOACs in NVAF patientsdate_rangeTime Frame:6 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A