A Pilot Trial to Assess the Feasibility of a Multicentre, Phase IV, Prospective, Randomized, Open-label, Two-arm Study With Blinded-endpoint Evaluation to Investigate Vitamin K Antagonist (VKA) Therapy Compared With Direct Oral Anticoagulant (DOAC) Therapy in Male and Female Participants With Atrial Fibrillation and Recent Ischemic Stroke While on a DOAC
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Feasibility - Recruitment
研究概览
简要总结
People with atrial fibrillation who have a stroke while receiving a DOAC are at increased risk of experiencing another stroke. Physicians do not know the best medication to prevent another stroke in this group of people. Options include continuing the same DOAC, switching to another DOAC or switching to warfarin.
The investigators of the SWITCH-AF trial are trying to find out whether switching to warfarin or continuing a DOAC is better for preventing stroke.
The purpose of this study, called a pilot study, is to test the study plan and to find out whether enough participants will join a larger study that answers the question. A pilot study involves a small number of participants and it is not expected to tell us which treatment is better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent provided.
- •Age >18 years.
- •Documented history of AF or atrial flutter.
- •Ischemic stroke while on a DOAC within 14 days prior to enrollment identified on imaging.
- •In the opinion of the investigator, it is safe to initiate oral anticoagulation with either a VKA or a DOAC within 24 hours of randomization-
排除标准
- •There is strong evidence for the qualifying stroke event to be associated with permanent discontinuation of DOAC therapy (for any reason)
- •Patient is unable or unwilling to take oral anticoagulation
- •History of intracranial bleeding.
- •Patient is on chronic hemodialysis or likely to need renal replacement therapy during the course of the trial.
研究组 & 干预措施
VKA Arm
Vitamin K Antagonist
干预措施: VKA (Drug)
DOAC Arm
Direct oral anticoagulant (locally approved)
干预措施: Direct Oral Anticoagulant (DOAC) (Drug)
结局指标
主要结局
Feasibility - Recruitment
时间窗: From site activation until the end of recruitment (approximately 24 months)
Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers
次要结局
- Feasibility - Adherence to Assigned Medication(Enrollment to final visit (average 12 months))
- Feasibility - Retention(At 6 months from randomization)