Article

The INTERACT pilot study demonstrated the feasibility of the
protocol, safety of early intensive blood pressure (BP) lowering, and effects on
hematoma expansion within 6hours of onset of intracerebral hemorrhage (ICH). This
article describes the design of the second, main phase, INTERACT2. INTERACT2 aims
to compare the effects of a management strategy of early intensive BP lowering
with a more conservative guideline-based BP management policy in patients with
acute ICH. This article also compares the baseline characteristics of the
patients included in France with the baseline characteristics of the patients
included in the pilot study INTERACT1. DESIGN OF THE STUDY: INTERACT2 is an
international, prospective, multicentre, open, assessor-blinded outcome (PROBE),
randomised, controlled trial. Patients with a systolic BP greater than 150mmHg
are centrally randomised to either to an intensive BP lowering treatment
(Systolic BP</=140mmHg within 1hour) or to a conservative treatment strategy
(target systolic BP of 180mmHg). A projected 2800 subjects are to be enrolled
from approximately 140 centres worldwide to provide 90% power (alpha 0.05) to
detect a beneficial effect of early treatment on the primary outcome. STUDY
OUTCOMES: The primary outcome is the combined endpoint of death and dependency
according to the modified Rankin Scale (mRS) at 90 days. The key secondary
outcome is the primary endpoint in those patients treated within 4hours of ICH.
Other predefined secondary outcomes are the separate components of the primary
endpoint, grades of physical function on the mRS, health-related quality of life
on the EuroQoL, recurrent stroke and other vascular events, days of
hospitalisation, requirement for permanent residential care, and unexpected
serious adverse events. The study is registered under NCT00716079,
ISRCTN73916115, and ACTRN12608000362392. POPULATION: As of early July, 152
patients have been included in France. When compared with the patients randomised
in the INTERACT1 pilot study, these patients are older, less likely to have had a
previous ICH, more often on antiplatelet or warfarin therapy, have a lower
diastolic BP, arere more severe clinically (higher NIHSS) and experience their
first ICH.
CI - Copyright (c) 2011 Elsevier Masson SAS. All rights reserved.

Langue : FRANCAIS