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NCT03699215: LEVOCEST
Clinical Trial in Patients Who Have Suffered a Heart Attack and Who Have Undergone Catheterization Treated With Levosimendan
Phase 3 trial testing Levosimendan in ST Elevation Myocardial Infarction in 184 participants. Status unknown.
30 April 2020
Quick facts
| Lead sponsor | Hospital Universitario de Canarias |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 184 |
| Start date | 17 November 2018 |
| Primary completion | 30 April 2020 |
| Estimated completion | 30 December 2021 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Levosimendan (LEVOSIMENDAN) — full drug profile →
- Placebos — full drug profile →
Conditions studied
- ST Elevation Myocardial Infarction — all drugs for ST Elevation Myocardial Infarction →
Sponsor
Hospital Universitario de Canarias
Who can join
Adults 18 to 85, any sex, with ST Elevation Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The disease under study is acute coronary syndrome with ST segment elevation, defined as patients presenting chest pain of anginal characteristics of more than 20 minutes of duration, with changes in the electrocardiogram consisting of ST segment elevation of 1 mm in two contiguous limb leads or 2 mm in two contiguous leads precordial. In a review carried out on patients treated in the investigator center with SCACEST, invetsigators found that, in a cohort of 250 patients, 85% of them presented alterations Segments of left ventricular contractility at 4 months after the acute episode. To verify that the Levosimendan administration reduces that percentage, at least 65%, investigators require to include in the study 83 patients in the experimental group and 83 in the control group, for a power of 80% and a confidence level of 95%. Assuming 10% of lost patients, it is required to include in the study 92 patients in the experimental group and 92 patients in the group control .
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03699215
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Levosimendan
Trials testing the same drug.
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- NCT05664191 — Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage · Phase 2 · recruiting
- NCT06021587 — Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection · unknown
- NCT05730907 — Efficacy and Clinical Outcomes of Levosimendan in E-CPR · unknown
- NCT05233202 — Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction · Phase 3 · unknown
Other recruiting trials for ST Elevation Myocardial Infarction
Currently open trials in the same condition.
- NCT05785897 — STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT · NA · recruiting
- NCT06795035 — Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution · recruiting
- NCT07058857 — The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocard · NA · recruiting
- NCT06465303 — A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEM · Phase 2 · recruiting
- NCT06535503 — Clinical Characteristics and Outcomes Among STEMI Patients With Cardiogenic Shock at Abu Dhabi City · recruiting
Other Hospital Universitario de Canarias trials
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 NCT03699215 (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 Hospital Universitario de Canarias
- Last refreshed: 11 February 2021
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/NCT03699215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing