An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill (Triple Pill”) strategy on top of standard of care, on the on time to first occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage (TRIDENT).

The George Institute for Global Health0 个研究点目标入组 1,800 人开始时间: 2016年3月11日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Adults (greater than or equal to 18 years) with a history of primary ICH that is confirmed by imaging (copy of the brain imaging report to be uploaded to the database, labelled with participant identification (ID) and with personal identifiers removed)
•Clinically stable, as judged by investigator
•Average of two resting SBP levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (National Heart Foundation of Australia [NHF] Guidelines). (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice)
•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
•No clear contraindication to any of the study treatments
•Provision of written informed consent

•Taking an ACE-I that cannot be switched to any of the following alternatives
•otelmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25mg, or
•oan equivalent class (ARB, CCB or thiazide [TZ]-like diuretic), or
•oa beta-blocker (BB)
•Contraindication to any of the study medications, in the context of currently prescribed BP-lowering medication
•Exclusion Criteria for MRI (as applies)
•Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal
•Unable to complete the study procedures and/or follow-up
•Females of child-bearing age and capability, who are pregnant or breast-feeding, or those of child-bearing age and capability who are not using adequate birth control
•Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
•Estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2
•Severe hepatic impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3x the upper limit of normal [ULN])
•Any other condition that in the opinion of the responsible physician investigator renders the patient unsuitable for the study (e.g. severe disability [i.e. simplified modified Rankin Scale (smRS) of 4-5] or significant memory or behavioural disorder)

发起方