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Recurrent Stroke Prevention Clinical Outcome Study

NCT01198496 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2012-07-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Losartan, Losartan and HCTZ, Amlodipine , Spironolactone

\<Study drugs and treatment steps\> Step 1: Losartan 50 mg in principle (other ARB is usable) Step 2: Combination drug containing losartan 50 mg and hydrochlorothiazide 12.5 mg Step 3: Combination drug containing losartan 50mg and HCTZ 12.5mg + amlodipine 5 mg Step 4: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 5 mg Step 5: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg Step 6: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg + spironolactone 25 mg

Sponsors & Collaborators

  • Biomedis International Ltd.

    lead OTHER

Principal Investigators

  • Kazuyuki Shimada, MD · RESPECT Study Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01198496 on ClinicalTrials.gov