Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 31,336
- 试验地点
- 1
- 主要终点
- Treatment Duration
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Stroke Prevention with Dabigatran in NVAF Patients
All NVAF patients above 18 years for age prescribed with Dabigatran during the study period
干预措施: Dabigatran (Drug)
Stroke Prevention with Rivaroxaban in NVAF Patients
All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Stroke Prevention with Apixaban in NVAF Patients
All NVAF patients above 18 years for age prescribed with Apixaban during the study period
干预措施: Apixaban (Drug)
结局指标
主要结局
Treatment Duration
时间窗: 6 years
DOACs for stroke prevention in NVAF patients including those with renal impairment
Daily dose
时间窗: 6 years
DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment
Demographic Characteristics
时间窗: 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
时间窗: Ever prior to index date
* Warfarin * Other Vitamin K antagonist(s)
Concurrent co-medication
时间窗: 6 years
* Anti-coagulants * Aspirin * Clopidogrel * Other
Dose posology
时间窗: 6 years
DOACs for stroke prevention in NVAF patients including those with renal impairment
Naive status and Non-naive status
时间窗: 6 years
DOACs for stroke prevention in NVAF patients including those with renal impairment
Risk factor categories
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Time-trends(6 years)