- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126516
Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline
Effects of Angiotensin II Receptor Blockers (ARB) and Angiotensin Converting Enzyme Inhibitors (ACEI) on Progression of Silent Brain Infarction and Cognitive Decline in Japanese Patients With Essential Hypertension in the Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypertension plays a major role in the development of cardiovascular diseases. Treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. Angiotensin converting enzyme inhibitor (ACEI), ramipril, showed a 32 % in relative risk of reduction in the Heart Outcomes Prevention Evaluation (HOPE) trial. Angiotensin II receptor blocker (ARB), losartan, also showed a 25 % in relative risk of reduction in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE).
Elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. However, no reports are seen on comparison of the effects of ARBs and ACEIs on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly.
The researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by Mini-Mental State Examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by ARB or ACEI.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- First Department of Internal Medicine, Nara Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs)
- Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging
Exclusion Criteria:
- Secondary hypertension
- Atrial fibrillation
- History or signs of cerebral disorders other than cerebrovascular disease
- Malignant tumor
- Chronic renal failure
- Severe congestive heart failure
- Hyperkalemia
- Stenosis of bilateral renal artery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Angiotensin II Receptor Antagonists group
|
any dosage, frequency, and duration
|
Active Comparator: 2
Angiotensin-converting Enzyme Inhibitors group
|
any dosage, frequency, and duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fatal and nonfatal stroke
Time Frame: two years
|
two years
|
Progression of silent brain infarction or white matter lesion on magnetic resonance imaging
Time Frame: two years
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause mortality
Time Frame: two years
|
two years
|
Fatal and nonfatal acute coronary syndrome
Time Frame: two years
|
two years
|
Admission for heart failure
Time Frame: two years
|
two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoshihiko Saito, MD, PhD, First Department of Internal Medicine, Nara Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Brain Ischemia
- Cognition Disorders
- Stroke
- Infarction
- Hypertension
- Cognitive Dysfunction
- Brain Infarction
- Molecular Mechanisms of Pharmacological Action
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Vasoconstrictor Agents
- Enzyme Inhibitors
- Angiotensin II
- Giapreza
- Angiotensinogen
- Angiotensin-Converting Enzyme Inhibitors
- Angiotensin Receptor Antagonists
Other Study ID Numbers
- 03-Ken-52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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