CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 9
- 主要终点
- Onset of ISTH Major Bleeding Event
研究概览
简要总结
- The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure.
- The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib") or atrial flutter. Most participants will be age 65 or older, and should already be taking apixaban or rivaroxaban.
- The investigators will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs.
- The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.
详细描述
Study hypothesis and design:
The study hypothesizes that apixaban will be superior to rivaroxaban for safety (using the International Society on Thrombosis and Haemostasis [ISTH] definition of major bleeding) and at least non inferior for efficacy among patients with atrial fibrillation (AF) or atrial flutter (AFL), henceforth collectively "AF." This is a phase 4, pragmatic, point of care, parallel group, unblinded randomized trial embedded in VA clinical care.
Enrollment and allocation:
Approximately 10,000 Veterans ages 65 years or older with AF and CHA2DS2-Vasc of 3 or more will be randomized 1:1 to apixaban or rivaroxaban; Veterans aged 22-64 may also enroll and will be included in exploratory analyses. Randomization uses site specific permuted blocks with random block sizes via a centralized Interactive Web Response System (IWRS).
Co Primary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Drug assignment will be unblinded and distributed through VA's usual mechanism for filling medications (i.e., local pharmacy or Consolidated Mail Outpatient Pharmacy [CMOP]).
Randomization: Allocation occurs via a centralized online tool (IWRS). Each site uses permuted-block randomization with random block sizes, pre-programmed before study start; no stratification is applied at randomization.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Male or female Veteran
- •Diagnosis of atrial fibrillation (AF) or atrial flutter (AFL) and currently taking either apixaban or rivaroxaban.
- •CHA2DS2-Vasc of 3 or more
- •Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study; notably use of antiplatelet agents or prior OAC use will not be an exclusion criterion:
- •Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication
- •Another indication for anticoagulation, such as pulmonary embolism
- •Contraindication to oral anticoagulation
- •Known bleeding diathesis
- •Documented current pregnancy or lactation in the EHR or self-reported current pregnancy or lactation
- •Known allergic reactions or intolerance to apixaban or rivaroxaban
- •Most recent estimated glomerular filtration rate (eGFR) is < 30 mL/minute/1.73m
- •An eGFR result must have been obtained within 18 months before randomization.
- •Known mechanical heart valve
- •Known moderate-severe mitral stenosis
- •Known history of left atrial occlusion, excision, or ligation
- •Current or planned use of systemic ritonavir, itraconazole, or ketoconazole (topical use of ketoconazole only is allowed)
- •Cardiac or thoracic surgery in the past 3 months
研究组 & 干预措施
Rivaroxaban Arm
Study participants will be randomized to daily oral administration of rivaroxaban 20 milligrams (mg) if creatinine clearance of 50 mL/min or more. Reduced dose rivaroxaban (15 mg once daily) will be given to participants with a creatinine clearance 15-50 mL/min.
干预措施: Rivaroxaban (Drug)
Apixaban Arm
Study participants will be randomized to twice daily oral administration of apixaban 5 milligrams (mg). Reduced dose apixaban (2.5 mg twice daily) will be given to participants who meet 2 of the 3 criteria: age 80 years or older, body weight of 60 kg or lower, serum creatinine of 1.5 mg/dL or higher
干预措施: Apixaban (Drug)
结局指标
主要结局
Onset of ISTH Major Bleeding Event
时间窗: 3 years
Hospitalization for first ISTH-defined major bleeding, as determined by ICD-10 codes associated with hospitalization. This is the primary safety outcome.
Time to First Stroke
时间窗: 3 years
Hospitalization for first stroke, as determined by ICD-10 codes associated with hospitalization. The primary efficacy outcome is time to first event of stroke or systemic embolism, or death of any cause, in days.
Time to First Systemic Embolism
时间窗: 3 years
Hospitalization for first systemic embolism, as determined by ICD-10 codes associated with hospitalization. The primary efficacy outcome is time to first event of stroke or systemic embolism, or death of any cause, in days.
Time to All-Cause Mortality
时间窗: 3 years
Time to all-cause mortality, as determined by VA data on vital status. The primary efficacy outcome is time to first event of stroke or systemic embolism, or death of any cause, in days.
次要结局
- All-Cause Mortality(3 years)
- Time to First Stroke(3 years)
- Time to First systemic embolism(3 years)
- Time to First Stroke, Systemic Embolism, or All-Cause Mortality(3 years)
- Time to First Hospitalization for Heart Failure, Myocardial Infarction, or Acute Coronary Syndrome(3 years)