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NCT00282360 Clinical Trial

Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Coronary Artery Disease Clinical Trial

Official title:
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282360
Other study ID # SR05-1-5
Secondary ID
Status Completed
Phase Phase 4
First received January 24, 2006
Last updated January 24, 2006
Start date February 1999
Est. completion date October 2003

Study information
Verified date May 2004
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of this study is that shifting cardiac metabolism from free fatty acids to glucose will improve myocardial ischemia

Description:

The present study will evaluate the effect of free fatty acid inhibition with Trimetazidine on silent myocardial ischemia and total ischemic burden in coronary artery disease patients with type II diabetes.

Patients will undergo ambulatory ECG monitoring at baseline and will be randomized to receive on top of thei standard anti-anginal therapy trimetazidine or placebo for 6 months. Patients will repeat the ambulatory ECG monitoring at the end of the study

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

coronary artery disease type II diabetes mellitus -

Exclusion Criteria:

unstable coronary artery syndromes impaired liver and kidney function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Trimetazidine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Outcome
Type Measure Description Time frame Safety issue
Primary total ischemic burden
Primary silent ischemia
Secondary symptomatic myocardial ischemia
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