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Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline

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ClinicalTrials.gov Identifier: NCT00126516
Recruitment Status : Completed
First Posted : August 4, 2005
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University

Study Description
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Brief Summary:
The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.

Condition or disease Intervention/treatment Phase
Brain Infarction Hypertension Drug: Angiotensin II Receptor Antagonists Drug: Angiotensin-converting Enzyme Inhibitors Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 Start Date : May 2004
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Angiotensin II Receptor Antagonists group
 Drug: Angiotensin II Receptor Antagonists
any dosage, frequency, and duration
Active Comparator: 2
Angiotensin-converting Enzyme Inhibitors group
 Drug: Angiotensin-converting Enzyme Inhibitors
any dosage, frequency, and duration


Outcome Measures
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Primary Outcome Measures :
  1. Fatal and nonfatal stroke [ Time Frame: two years ]
  2. Progression of silent brain infarction or white matter lesion on magnetic resonance imaging [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Fatal and nonfatal acute coronary syndrome [ Time Frame: two years ]
  2. Admission for heart failure [ Time Frame: two years ]
  3. All cause mortality [ Time Frame: two years ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126516


Locations
Japan
First Department of Internal Medicine, Nara Medical University
Kashihara, Nara, Japan, 634-8522
Sponsors and Collaborators
Nara Medical University
Investigators
Principal Investigator: Yoshihiko Saito, MD, PhD First Department of Internal Medicine, Nara Medical University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yoshihiko Saito, Professor, Nara Medical University
ClinicalTrials.gov Identifier: NCT00126516     History of Changes
Other Study ID Numbers: 03-Ken-52
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Yoshihiko Saito, Nara Medical University:
silent brain infarction
cognitive decline
Angiotensin II Type 1 Receptor Blockers
Angiotensin-Converting Enzyme Inhibitors
hypertension

Additional relevant MeSH terms:
Hypertension
Infarction
Cognitive Dysfunction
Brain Infarction
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Enzyme Inhibitors
Angiotensinogen
Angiotensin II
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors