Study of Antithrombotic Treatment after Intracerebral Haemorrhage (STATICH)

Oslo University Hospital0 个研究点目标入组 500 人开始时间: 2017年7月7日最近更新: 2018年7月23日

研究概览

暂无简介。

•Patient age =18 years.
•Spontaneous, primary ICH, of =1 day, but not more than 180 days’ duration, i.e.:
•- No preceding traumatic brain injury, based on history from the patient/witness of spontaneous symptom onset, and brain imaging appearances consistent of spontaneous ICH (i.e. any brain/bone/soft tissue appearances of trauma must have occurred secondary to a spontaneous ICH)
•- No ‘secondary’ or underlying structural cause (e.g. haemorrhagic transformation of an ischaemic stroke, aneurysm, tumour, arteriovenous malformation, or intracerebral venous thrombosis)
•Patient has indication for antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of ischaemic events, either antiplatelet drugs (for patients with vascular disease), or anticoagulant drug for patients with atrial fibrillation.
•Consent to randomisation from the patient (or personal/legal/professional representative if the patient does not have mental capacity, and waiver of consent is accepted in the patients country).
•CT or MRI (for patients in MRI sub-study) is performed before randomisation.
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves).
•Contraindications to the antithrombotic drug that will be administered.
•Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.See protocol for details
•For patients in MRI substudy: Contraindication for the brain MRI
•Malignancy With life expectancy less than 2 years

发起方

Oslo University Hospital