Recurrent Stroke Prevention Clinical Outcome Study
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
1. Objectives and Hypothesis
1. Objectives:
This study evaluates whether strict BP management is useful for the prevention of
recurrent stroke.
Hypertensive patients with history of stroke are treated with stepwise multi-drug
therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group
and less stricter BP target <140/90 mmHg or <130/80 mmHg for patients with current
DM/CKD/MI in the standard BP control group. The participants under the BP treatment
achieving their respective BP target will be followed for recurrence of stroke. The
study continues until the number of patients with the first recurrent stroke
reaches a total of 330 between the two groups. The occurrence rates of recurrent
stroke will be compared between the two groups.
2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control
group having lower BP target: <120/80 mmHg* than in a standard BP control group
having BP target <140/90 mmHg or <130/80 mmHg for current DM/CKD/MI in patients
with hypertension.
2. Study design This will be a multicenter, randomized, open-label study. The study
consists of a screening period, a titration period and a follow-up period. The screening
period is a period between the date of consent and the enrollment date. Hypertensive
patients with history of stroke are randomly assigned to either the strict BP control
group having the target of <120/80 mmHg or the standard BP control group having the
target of <140/90 mmHg without current DM, CKD or MI and <130/80 mmHg with current DM,
CKD or MI. The titration period is the period finding a treatment which achieves target
BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy
using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and
aldosterone antagonist. The participants will be observed under the BP management for
their respective BP target. The study will be continued until the number of patients
with the first recurrent stroke reaches a total of 330 between two groups. The follow-up
period will be 3 years.
The recurrent rates of stroke in both groups will be compared from various aspects, and
strict BP management will be investigated on the usefulness in prevention of recurrent
stroke.