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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University
ClinicalTrials.gov Identifier:
NCT00126516
First received: August 3, 2005
Last updated: October 28, 2013
Last verified: October 2013

August 3, 2005
October 28, 2013
May 2004
June 2013   (final data collection date for primary outcome measure)
  • Fatal and nonfatal stroke [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Progression of silent brain infarction or white matter lesion on magnetic resonance imaging [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Fatal and nonfatal stroke
  • Progression of silent brain infarction
  • Cognitive decline
Complete list of historical versions of study NCT00126516 on ClinicalTrials.gov Archive Site
  • Fatal and nonfatal acute coronary syndrome [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Admission for heart failure [ Time Frame: two years ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Progression of white matter lesion
  • Progression of brain atrophy
  • Progression of carotid atherosclerosis
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Brain Infarction
  • Hypertension
  • Drug: Angiotensin II Receptor Antagonists
    any dosage, frequency, and duration
  • Drug: Angiotensin-converting Enzyme Inhibitors
    any dosage, frequency, and duration
  • Active Comparator: 1
    Angiotensin II Receptor Antagonists group
    Intervention: Drug: Angiotensin II Receptor Antagonists
  • Active Comparator: 2
    Angiotensin-converting Enzyme Inhibitors group
    Intervention: Drug: Angiotensin-converting Enzyme Inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00126516
03-Ken-52
Yes
Yoshihiko Saito, Nara Medical University
Nara Medical University
Not Provided
Principal Investigator: Yoshihiko Saito, MD, PhD First Department of Internal Medicine, Nara Medical University
Nara Medical University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP