NCT00282360

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_4 coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
Last Updated

January 26, 2006

Status Verified

May 1, 2004

First QC Date

January 24, 2006

Last Update Submit

January 24, 2006

Conditions

Coronary Artery DiseaseType II Diabetes Mellitus

Keywords

coronary artery diseasediabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • total ischemic burden

  • silent ischemia

Secondary Outcomes (1)

  • symptomatic myocardial ischemia

Interventions

TrimetazidineDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary artery disease type II diabetes mellitus -

You may not qualify if:

  • unstable coronary artery syndromes impaired liver and kidney function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Giuseppe Marazzi, MD

    H San Raffaele EUR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 26, 2006

Study Start

February 1, 1999

Study Completion

October 1, 2003

Last Updated

January 26, 2006

Record last verified: 2004-05