NL-OMON50507已完成2 期
Apixaban versus antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation. A randomised phase II clinical trial. - APACHE-AF
niversitair Medisch Centrum Utrecht0 个研究点目标入组 101 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Intracerebral haemorrhage (including isolated spontaneous intraventricular
- •haemorrhage), documented with CT or MRI, during treatment with anticoagulation
- •(VKA, any direct thrombin inhibitor, any factor Xa inhibitor, or
- •(low-molecular-weight) heparin at a therapeutic dose).
- •The haemorrhage has occurred between 7 and 90 days before randomization.
- •Diagnosis of (paroxysmal) non-valvular AF, documented on electrocardiography.
- •A CHA2DS2VASc score * 2. The item Stroke in the Stroke/TIA/TE item refers to
- •ischaemic stroke, not haemorrhagic stroke.*
- •Score on the modified Rankin scale (mRS) *4.
- •Equipoise regarding the optimal medical treatment for the prevention of stroke.
- •The clinical equipoise should be self-reported by the attending neurologist
- •after reviewing the all relevant information available for the individual
- •Age * 18 years.
- •Written informed consent by the patient or by a healthcare proxy
排除标准
- •Conditions other than atrial fibrillation for which the patient requires
- •long-term anticoagulation.
- •A different clinical indication for the use of an APD even when treated with
- •apixaban, such as clopidogrel for recent coronary stenting.
- •Mechanical prosthetic heart valve (biological prosthetic heart valves are
- •allowed) or rheumatic mitral valve disease.
- •Serious bleeding event (see protocol chapter 7.1.4) in the previous 6 months,
- •except for intracerebral haemorrhage.
- •High risk of bleeding (e.g., active peptic ulcer disease, a platelet count of
- •<100,000/mL or haemoglobin level of <6.2 mMol/L, ischaemic stroke in the
- •previous 7 days (patients are eligible thereafter), documented haemorrhagic
- •tendencies, or blood dyscrasias).
- •Current alcohol or drug abuse.
- •Life expectancy of less than 1 year.
- •Severe renal insufficiency (a serum creatinine level of more than 221 *mol per
- •liter or a calculated creatinine clearance of <15 ml per minute).
- •Alanine aminotransferase or aspartate aminotransferase level greater than 2
- •times the upper limit of the normal range or a total bilirubin more than 1.5
- •times the upper limit of the normal range, unless an benign causative factor
- •(e.g. Gilbert*s syndrome) is known or identified.
- •Allergy to apixaban.
- •Use of strong cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) inhibitors
- •(e.g. systemic azole-antimycotics as ketoconazole or HIV protease inhibitors
- •such as ritonavir).
- •Pregnancy or breastfeeding.
- •Women of childbearing potential: any woman who has begun menstruation and is
- •not postmenopausal or otherwise permanently unable to conceive. A
- •postmenopausal woman is defined as a woman who is over the age of 45 and has
- •not had a menstrual period for at least 12 months.
研究者
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