Coronary Artery DiseasePhase 4NCT00282360
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
A Phase 4 study testing Trimetazidine in people with Coronary Artery Disease and Type II Diabetes Mellitus, run by IRCCS San Raffaele.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Type II Diabetes Mellitus
- What is being tested?
- Trimetazidine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 1999to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease type II diabetes mellitus -
Who cannot join
- unstable coronary artery syndromes impaired liver and kidney function
- -
About this study
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
Read the detailed 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
- Conditions
- Coronary Artery Disease, Type II Diabetes Mellitus
- Being tested
- Trimetazidine
- Keywords
- coronary artery disease, diabetes mellitus
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
total ischemic burden
silent ischemia
Secondary outcomes (1)
symptomatic myocardial ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startFeb 1999
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Marazzi, MD, Principal investigator, H San Raffaele EUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282360
- Sponsor's protocol ID
- SR05-1-5
- Status last verified
- May 2004
- First submitted
- 24 Jan 2006
- Last updated
- 26 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT00282360
- Acronym / sponsor ID
- SR05-1-5
- Conditions
- Coronary Artery Disease, Type II Diabetes Mellitus
- Keywords
- coronary artery disease, diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Feb 1999
- Study completion
- Oct 2003
- First posted
- 26 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- coronary artery disease type II diabetes mellitus -
Key exclusion criteria (2 listed)
- unstable coronary artery syndromes impaired liver and kidney function
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimetazidine | Drug | – |
Primary outcome
total ischemic burden
silent ischemia
1 secondary outcome
symptomatic myocardial ischemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Marazzi, MD principal investigator
H San Raffaele EUR
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimetazidine in people with Coronary Artery Disease and Type II Diabetes Mellitus, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total ischemic burden. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2006.