ACTRN12623000949684尚未招募2 期
Evaluating Covert cerebrovascular cHanges to Optimise anticoagulant therapy Efficacy and Safety in Atrial Fibrillation Pilot
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Adults (age >=18 years).
- •2.Have non-valvular atrial fibrillation (AF) or atrial flutter (AFL) as documented by electrocardiography (ECG) (12-lead ECG, rhythm strip, or Holeter) in the past 6 months before enrolment, regardless of AF clinical patterns.
- •3.Take OAC at study entry or willing to receive OAC for thromboprophylaxis without any contradiction, and standard-dose OAC is appliable.
- •4.Willing to undergo brain MRI.
- •5.Willing to participate after being told the trial information (purpose and procedures) and provide written informed consent by the participant or an appropriate legal surrogate.
排除标准
- •1.History of heart valve disease (i.e., prosthetic valve or hemodynamically relevant valve disease).
- •2.AF or AFL due to reverse causes of cardiac surgery, pulmonary embolism, and untreated hyperthyroidism.
- •3.Known presence of atrial myxoma, left ventricular thrombus, or active endocarditis.
- •4.Severe, disabling stroke (modified Rankin scale [mRS] score of 4 to 5) within the past 3 months, or any stroke within the past 14 days, or TIA within 3 days before enrolment.
- •5.An obvious impairment of renal function (serum creatine >=1.5 mg/dL [133 µmol/L] or creatinine clearance [CrCL, Cockcroft-Gault Equation] <= 50 mL/min) or hepatic function (persistent alanine transaminase [ALT], aspartate transaminase [AST], or alkaline phosphatase [ALP] >3x upper limit of the normal range [ULN], acute clinical hepatitis, chronic active hepatitis, or cirrhosis).
- •6.Any other conditions associated with increased bleeding risk including:
- •a.Major surgery within the past 2 months or planned surgery or intervention within the next 3 months.
- •b.Anemia (hemoglobin level <100 g/L) or thrombocytopenia (platelet count <100/µL).
- •c.Gastrointestinal (GI) hemorrhage within the past 6 months or symptomatic gastroduodenal ulcer disease documented by endoscopy in the previous 30 days.
- •d.Sustained uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg and/or diastolic blood pressure [DBP] >100 mmHg).
- •e.Needs anticoagulant therapy for disorders other than AF.
- •f.Known intracranial neoplasm, arteriovenous malformation (AVM), or aneurysm before randomisation.
- •7.Not eligible for MRI examination, such as decompensated heart failure that hinders flat lying during MRI scanning, claustrophobia, and metallic foreign body or iatrogenic implantable device contradicted to MRI.
- •8.Have malignancy or other serious concomitant diseases with a life expectancy of <2 years.
- •9.Women who are pregnant or of childbearing potential who refuse to use medically acceptable contraception throughout the trial.
- •10.Participating in another trial of anticoagulant therapy that conflicts with the ECHOES-AF Pilot.
- •11.Any other condition, in the opinion of investigators, that renders the patient unsuitable for the trial and would compromise adherence and safe participation (e.g. drug addiction, alcohol abuse, etc.).
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