Diabetes MellitusPhase 3TrimetaNCT03715582
Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes
A Phase 3 study testing trimetazidine in people with Diabetes Mellitus and Angina, Unstable, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Introduction: Recent studies have suggested that trimetazidine may help reduce myocardial damage following percutaneous coronary intervention. However, the evaluation of the potential of this medication in the reduction of myocardial damage in patients with diabetes mellitus and unstable angina, in a prospective and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Angina, Unstable
- What is being tested?
- trimetazidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 1 Oct 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women aged> 18 years.
- Diagnosis of unstable angina with chest pain at least 2 hours after arrival at the emergency unit.
- Measurement of troponin less than the upper limit of the normality of the method.
- Indication of cardiac catheterization and need for percutaneous coronary intervention with uniarterial stent within 24 hours of admission.
- No known allergy to trimetazidine.
- Prior diagnosis of diabetes mellitus under specific treatment.
- ClCr> 30 mL / min.
- Signed consent form.
Who cannot join
- Pregnancy.
- Hemodynamic instability (pulmonary congestion / systolic blood pressure less than 90 mmHg).
- SCA with ST elevation or troponin elevation.
- Body mass index greater than 40 kg / m2.
- Use of oral anticoagulant.
- Orotracheal intubation.
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- Left ventricular outflow tract obstruction.
- Allergy to iodinated contrast.
- Thoracic trauma in the last 30 days.
- Previous surgical myocardial revascularization.
- Presence of ventricular arrhythmias.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HMFMUSP
São Paulo, 05403000
Alexandre Soeiro, MD, 5511-2661-5299, alexandre.soeiro@bol.com.br
About this study
Official title: PROSPECTIVE ANALYSIS BETWEEN TRIMETAZIDINE Versus PLACEBO IN MYOCARDIAL INJURY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH INSTANT ANGINA AND DIABETES MELLITUS
Introduction: Recent studies have suggested that trimetazidine may help reduce myocardial damage following percutaneous coronary intervention. However, the evaluation of the potential of this medication in the reduction of myocardial damage in patients with diabetes mellitus and unstable angina, in a prospective and randomized way, has not yet been described. Objective: The aim of this study was to evaluate the efficacy and safety of the use of trimetazidine versus placebo in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Myocardial damage will be measured by means of ultrasensitive Troponin dosages. Expected results: The use of trimetazidine reduces myocardial damage in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty.
- Conditions
- Diabetes Mellitus, Angina, Unstable
- Being tested
- trimetazidine, Placebo Oral Tablet
- Medical subject headings
- Diabetes Mellitus, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trimetazidineDrug
Pills of masking drug - trimetazidine
Placebo Oral TabletDrug
Also called placebo
Pills of masking drug - placebo
| Study group | Role | What they receive |
|---|---|---|
| trimetazidine | Experimental | The randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When the patient is randomized to the trimetazidine pill group, he / she will initiate the medication at 70 mg oral dose (2 tablets of Vastarel ® MR 35 mg single dose) 2 hours before the procedure. Receives: Drug: trimetazidine |
| placebo | Experimental | The randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When randomized to the placebo oral tablets group, the patient will receive placebo (orally, 2 single dose tablets) also 2 hours prior to PCI. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak values of troponin and CKMB after PCI
comparing groups for peak values of troponin and CKMB after PCI.
Measured: 24 hours
Secondary outcomes (10)
peak values of CRP
Comparison between groups for peak values of CRP after PCI.
Measured: 24 hours
peak values of creatinine
Comparison between groups for peak values of creatinine after PCI.
Measured: 24 hours
peak values of leukogram
Comparison between groups for peak values of leukogram after PCI.
Measured: 24 hours
occurrence of sustained ventricular arrhythmia
Combined comparison between the occurrence of sustained ventricular arrhythmia
Measured: 24 hours
occurrence of cardiogenic shock,
Combined comparison between the occurrence of cardiogenic shock,
Measured: 24 hours
occurrence of cardiorespiratory arrest,
Combined comparison between the occurrence of cardiorespiratory arrest
Measured: 24 hours
occurrence of worsening of renal function
Combined comparison between the occurrence of worsening of renal function (increase of 0.5 mg / dL in relation to admission creatinine or 25% above baseline)
Measured: 24 hours
occurrence of need for reintervention
Combined comparison between the occurrence of need for reintervention
Measured: 24 hours
occurrence of cerebrovascular accident
Combined comparison between the occurrence of cerebrovascular accident
Measured: 24 hours
occurrence of death
Combined comparison between the occurrence of death
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mucio Tavares, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715582
- Sponsor's protocol ID
- PSInCor-Trimetazidine
- Acronym
- Trimeta
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE ANALYSIS BETWEEN TRIMETAZIDINE Versus PLACEBO IN MYOCARDIAL INJURY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH INSTANT ANGINA AND DIABETES MELLITUS
- ClinicalTrials.gov ID
- NCT03715582
- Acronym / sponsor ID
- Trimeta / PSInCor-Trimetazidine
- Conditions
- Diabetes Mellitus, Angina, Unstable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 23 Oct 2018 (actual)
- 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.
Introduction: Recent studies have suggested that trimetazidine may help reduce myocardial damage following percutaneous coronary intervention. However, the evaluation of the potential of this medication in the reduction of myocardial damage in patients with diabetes mellitus and unstable angina, in a prospective and randomized way, has not yet been described. Objective: The aim of this study was to evaluate the efficacy and safety of the use of trimetazidine versus placebo in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Myocardial damage will be measured by means of ultrasensitive Troponin dosages. Expected results: The use of trimetazidine reduces myocardial damage in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trimetazidine | Experimental | Drug: trimetazidineThe randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When the patient is randomized to the trimetazidine pill group, he / she will initiate the medication at 70 mg oral dose (2 tablets of Vastarel ® MR 35 mg single dose) 2 hours before the procedure. |
| placebo | Experimental | Drug: Placebo Oral TabletThe randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When randomized to the placebo oral tablets group, the patient will receive placebo (orally, 2 single dose tablets) also 2 hours prior to PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult men and women aged> 18 years.
- Diagnosis of unstable angina with chest pain at least 2 hours after arrival at the emergency unit.
- Measurement of troponin less than the upper limit of the normality of the method.
- Indication of cardiac catheterization and need for percutaneous coronary intervention with uniarterial stent within 24 hours of admission.
- No known allergy to trimetazidine.
Key exclusion criteria (11 listed)
- Pregnancy.
- Hemodynamic instability (pulmonary congestion / systolic blood pressure less than 90 mmHg).
- SCA with ST elevation or troponin elevation.
- Body mass index greater than 40 kg / m2.
- Use of oral anticoagulant.
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 |
|---|---|---|
| trimetazidinePills of masking drug - trimetazidine | Drug | trimetazidine |
| Placebo Oral TabletAlso: placeboPills of masking drug - placebo | Drug | placebo |
Primary outcome
peak values of troponin and CKMB after PCI
Time frame: 24 hours
comparing groups for peak values of troponin and CKMB after PCI.
10 secondary outcomes
peak values of CRP
Time frame: 24 hours
peak values of creatinine
Time frame: 24 hours
peak values of leukogram
Time frame: 24 hours
occurrence of sustained ventricular arrhythmia
Time frame: 24 hours
occurrence of cardiogenic shock,
Time frame: 24 hours
occurrence of cardiorespiratory arrest,
Time frame: 24 hours
occurrence of worsening of renal function
Time frame: 24 hours
occurrence of need for reintervention
Time frame: 24 hours
occurrence of cerebrovascular accident
Time frame: 24 hours
occurrence of death
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mucio Tavares, MD principal investigator
Unidade Clínica de Emergência
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trimetazidine in people with Diabetes Mellitus and Angina, Unstable, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Soeiro, MD (+55112661-5299, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak values of troponin and CKMB after PCI (time frame: 24 hours). 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 24 Oct 2018.