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NCT number NCT01198496
Study type Interventional
Source Biomedis International Ltd.
Contact Hiroko Usami, PhD
Phone 81-1-3-6252-3282
Email hiroko-u@biomedis.co.jp
Status Recruiting
Phase Phase 4
Start date October 2010
Completion date December 2019

Clinical Trial 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.


Clinical Trial Description

Rationale for Study Duration Predicting that strict BP control reduces the relative risk of recurrent stroke by 30% during the planned observation period of 3 years, the number of participants necessary to detect the recurrent stroke with rate of 2.5%/year and 7.5%/3 years is 2482 patients per group with a detection power of 90% and α-error of 0.05. A drop-out rate is estimated as 20%.

Therefore, the study will be continued for 3 years until a total of 330 patients with recurrent stroke in both groups are identified.

Rationale for Dosing Regimen One of ARB, losartan, is chosen for Step 1 therapy, because angiotensin II receptor blocker (ARB) is preferred as the first line of anti-hypertensives. Furthermore, a stepwise combination therapy of BP lowering drugs diuretic, hydrochlorothiazide, and calcium channel blocker, amlodipine, will be used, because the Japanese guidelines recommend the combination for BP control in prevention of recurrent stroke. (Step 2 to Step 5). Finally (as Step 6), a selective aldosterone antagonist, spironolactone, will be added for the treatment of with refractory hypertensive patients whose BP does not reach to the target.

Treatment Plan The dosages of study drugs will be determined according to the package insert for the drug.

Patients who are not treated with antihypertensive agent or treated with one antihypertensive agent at enrollment will start from Step 1. Patients who are treated with two antihypertensive agents at enrollment will start from Step 2.

In principle, treatment duration will be for 4 weeks at each step.


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


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