Optimal Blood Pressure and Cholesterol Targets for Preventing Recurrent Stroke in Hypertensives
Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
Summary
Stroke is one of the major causes not only of mortality, but of disease burden worldwide,
because of residual disability and cognitive decline. Although blood pressure lowering has
been clearly shown to be the most effective means for primary and secondary prevention of
stroke, the systolic blood pressure (SBP) levels to achieve by treatment in order to optimize
prevention results are unknown, and whether SBP levels lower than those usually recommended
are accompanied by further or reduced benefits is undecided yet. Likewise, while low-density
lipoprotein cholesterol (LDL-C) lowering by statins has been shown to be associated with
primary and secondary stroke prevention, whether more intense lowering is or is not of
further benefit is unknown. The Stroke in Hypertension Optimal Treatment Trial (ESH-CHL-SHOT)
is a factorial 3 x 2 arm, multicenter, randomized clinical trial designed to test the
hypothesis that in elderly patients at high risk of recurrent stroke (previous recent stroke
or TIA) antihypertensive treatment programs aimed at reducing SBP to the usually recommended
values (< 145 to 135 mmHg), to a lower goal (< 135 to 125 mmHg) or to even lower values (<
125 mmHg) will result in progressively greater reductions in recurrent stroke, incidence of
cardiovascular outcomes and cognitive decline. Parallely, the preventive efficacy of more and
less intense LDL-C reductions will be tested on the same outcomes.
Phase:
Phase 4
Details
Lead Sponsor:
Istituto Auxologico Italiano
Collaborators:
Chinese Hypertension League European Society of Hypertension