European Blood Pressure Intensive Control after Stroke-Pilot trial (EPICS-Pilot)

Stroke is the second leading cause of death, the leading cause of new disability and a major contributing cause of dementia and healthcare costs in the world. About one-third of recovered stroke survivors will have second stroke or heart attack by 5 years. High blood pressure (hypertension) is the leading treatable condition contributing to about half of all stroke world-wide.

Reducing systolic blood pressure (SBP, the ‘top’ blood pressure number) to less than 140 is proven to prevent many second strokes and heart attacks in stroke survivors. However it is unknown if lower SBP reduction than 140 is beneficial.

Aim:

We aim to do an initial (pilot) randomised (where patients are randomly-allocated to different treatment approaches) trial in Ireland and 7 leading European hospitals to test feasibility for a much larger study to answer this question. In preparation for the larger trial, this initial study will test feasibility, aspects of study design and will establish governance, data-management, and study procedures. The larger trial (European blood Pressure Intensive Control after Stroke trial [EPICS]) will include approximately 5,000 patients at 200 hospitals. We will apply for EU funding of the larger trial following the pilot study.

Methods:

The pilot study will compare safety, acceptability, benefit, and other feasibility measures of two target SBP-lowering strategies (goal 115-125 versus 130-139).

Consenting patients with non-severe stroke, aged 40 or more, with SBP greater than 130 and who are capable of participating will be included and randomly-allocated (by computer) to one of the 2 SBP treatment strategies. They will have home-monitored SBP adjusted at regular visits until in target range, using currently-approved medications.

For the pilot, the main outcome will be SBP in each group at study end (18 months). Other outcomes will be: measures of feasibility, side-effects, safety, quality-of-life, thinking, patient feedback.

Award Date: 04 December 2020
Award Value: €€399,384.00
Principal Investigator: Professor Peter Kelly
Host Institution: University College Dublin
Scheme: DIFA 2020