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临床试验/NCT03441633
NCT03441633已完成不适用

APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)

Pfizer1 个研究点 分布在 1 个国家目标入组 51,690 人开始时间: 2016年2月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
51,690
试验地点
1
主要终点
Number of Participants by Comorbidity

研究概览

简要总结

Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

详细描述

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

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

入选标准

  • Patients more than 18 years-old.
  • Patients diagnosed with NVAF registered in primary care according to ICD-
  • Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
  • Continuous enrolment in the 12 months pre-index.

排除标准

  • Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
  • Lost to follow-up (e.g. transfer to primary care center non-ICS).

研究组 & 干预措施

Group 1. Apixaban

Patients who are on treatment with apixaban.

1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

1b. patients who previously have been treated with VKA in the 12 months before index date.

干预措施: apixaban (Drug)

Group 2. VKA

Patients who are on treatment with VKA.

2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

2b. patients who previously have been treated with VKA in the 12 months before index date.

干预措施: VKA (Drug)

Group 3. Dabigatran

Patients who are on treatment with dabigatran.

3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

3b. patients who previously have been treated with VKA in the 12 months before index date.

干预措施: dabigatran (Drug)

Group 4. Rivaroxaban

Patients who are on treatment with rivaroxaban.

4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

4b. patients who previously have been treated with VKA in the 12 months before index date.

干预措施: rivaroxaban (Drug)

结局指标

主要结局

Number of Participants by Comorbidity

时间窗: Up to 12 months after date of first prescription

Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.

Risk of Thromboembolic Events: CHADS2 Score

时间窗: Up to 12 months prior to enrollment

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age \>=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.

Risk of Thromboembolic Events: CHA2DS2Vasc Score

时间窗: Up to 12 months prior to enrollment

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, \>=65 and \<75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age \>=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.

Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year

时间窗: Up to 12 months after date of first prescription

Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.

Number of Participants by Their Sociodemographic Characteristics: Smoking Habit

时间窗: Day 1

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.

Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit

时间窗: Day 1

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.

Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

时间窗: Day 1

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\^2).

Number of Participants by Their Sociodemographic Characteristics: MEDEA

时间窗: Day 1

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.

Risk of Bleeding Events: HAS-BLED Score

时间窗: Up to 12 months prior to enrollment

Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and \>3 = high risk of bleed per 100 participants-year.

Number of Participants by Comedications

时间窗: Up to 30 days after date of first prescription

Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.

Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)

时间窗: Up to 12 months after date of first prescription

MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as \<80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as \>120% of MPR.

International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

时间窗: Up to 12 months after date of first prescription

INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).

Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

时间窗: Up to 12 months after date of first prescription

TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).

Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)

时间窗: Up to 12 months after date of first prescription

NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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