EUCTR2014-000112-33-NL进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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) 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.
- •Age >= 18 years.
- •Written informed consent by the patient or by a legal representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
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 if 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 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 µmol 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
相似试验
招募中
不适用
Apixaban versus antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation. A randomised phase II clinical trial.ApixbanIntracerebral haemorrhageAntiplatelet drugsAtrial fibrillationHersenbloedingPlaatjesremmersAtriumfibrillerenNL-OMON27026MC Utrecht100
已完成
2 期
Apixaban After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial FibrillationAtrial FibrillationCerebral HemorrhageNCT02565693UMC Utrecht101
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.brain haemorrhageIntracerebral haemorrhage100075211000796310014523NL-OMON50507niversitair Medisch Centrum Utrecht101
尚未招募
2 期
Comparison of dalteparin and apixaban in thromboprophylaxisThrombosis in bone marrow transplant patients.Other complications of bone marrow transplantT86.09IRCT20100127003210N25Shahid Beheshti University of Medical Sciences60
进行中（未招募）
不适用
Clinical trial to evaluate treatment after percutaneous aortic valve implantatioEUCTR2011-005784-24-ESAndres Iñiguez Romo120