Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) - TRIDENT

The George Institute for Global Health, University of New South Wales0 个研究点目标入组 1,500 人开始时间: 2018年5月15日最近更新: 2020年8月18日

适应症

试验速览

暂无简介。

•1. Adults (=18 years) up to 12 months after symptom onset of stroke due to primary intracerebral haemorrhage (ICH) confirmed by brain imaging.
•2. Clinically stable, as judged by investigator
•3. Two resting systolic BP (SBP) levels, measured 5 minutes apart in the range 130-160mmHg recorded in a seated position. (Patients with higher SBP can be included if it is considered by attending clinician that management is consistent with local standards of clinical practice)
•4. Geographical proximity to the recruiting hospital and/or follow-up medical clinic site to allow ready access for in-person clinic visits during follow-up
•5. Provision of written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•1. Taking an ACE inhibitor antihypertensive drug that cannot be switched to any of the following alternatives:
•o telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or
•o an equivalent class (angiotensin receptor blocker, calcium channel blocker, or thiazide-like diuretic), or
•o a beta-blocker
•2. Contraindication to any of the study medications, in the context of currently prescribed BP lowering medication
•3. Unlikely/unable to complete the study procedures and/or follow-up
•4. Females of child bearing age and capability, who are pregnant or breast-feeding, or those not using adequate contraception
•6. Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
•7.Estimated glomerular filtration rate (eGFR) <30 mL/min ?
•8. Severe hepatic impairment (ALT or AST >3x the upper limit of normal [ULN])
•9. Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study (e.g. severe disability (ie modified Rankin Scale [mRS] score of 4-5] or significant memory or behavioural disorder or hyperkalaemia and/or hyponatremia, defined by local lab criteria)

发起方

The George Institute for Global Health, University of New South Wales