European Blood Pressure Intensive Control After Stroke

Summary

Participation Requirements

Description

Background: Stroke is the third leading cause of global death, the leading cause of acquired disability and contributes substantially to dementia, cognitive decline, and healthcare costs. Global epidemiological studies such as INTERSTROKE and the Global Burden of Disease study estimated that hyperte...

Background: Stroke is the third leading cause of global death, the leading cause of acquired disability and contributes substantially to dementia, cognitive decline, and healthcare costs. Global epidemiological studies such as INTERSTROKE and the Global Burden of Disease study estimated that hypertension is the leading modifiable risk factor for stroke, with a population attributable risk of approximately 50%. Recurrent vascular events (stroke, coronary events, vascular death) cause significant morbidity in ischaemic stroke survivors, affecting approximately 30% at 5 years. Blood-pressure reduction is a proven, inexpensive strategy to prevent stroke with benefits widely-generalizable in developed and developing countries. No randomised trials have demonstrated the efficacy and safety of SBP reduction to prevent secondary vascular events after ischaemic stroke to levels of about 120mmHg compared with 130-139mmHg. Consequently, most guidelines recommend reduction of systolic blood pressure (SBP) less than 140mmHg. Aim: The aim is to conduct an initial pilot randomised trial in Ireland and 7 leading European centres involved in the European Stroke Organisation Trials Alliance. This feasibility study will assess key design aspects and establish trial governance, data management, and procedures in preparation for a larger definitive trial. Methods: Design: Prospective, open-label, blinded endpoint assessed (PROBE) randomised, parallel-group pilot trial, comparing safety, efficacy, and other feasibility measures of two target SBP goals (intervention 115-125 mmHg, control 130-139 mmHg).

Tracking Information