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NCT03715582: Trimeta
Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes
Phase 3 trial testing trimetazidine in Diabetes Mellitus in 120 participants. Status unknown.
1 October 2020
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 October 2018 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- trimetazidine (TRIMETAZIDINE) — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Angina, Unstable — all drugs for Angina, Unstable →
Sponsor
University of Sao Paulo General Hospital
Who can join
18 and older, any sex, with Diabetes Mellitus or Angina, Unstable. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03715582
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03715582 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 24 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03715582.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing