Controlled Level EVERolimus in Acute Coronary Syndromes
NCT ID: NCT01529554
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2015-01-08
2021-11-29
Brief Summary
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The objectives of this study are to evaluate the effects of mTOR inhibition (everolimus) on infarct size, myocardial function and inflammation in patients with ST-Elevation Myocardial Infarction.
The efficacy objectives are:
1. (1° endpoint):
To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up measured by MRI (Late Gadolinium Enhancement (LGE) for transmurality).
2. (2° endpoint):
To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up evaluated by MRI.
3. (3° endpoints):
1. Change of left ventricular volume from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up measured by MRI.
2. Change of biomarkers from time of coronary angiography to 30 days follow-up including a time-course (AUC). Biomarkers comprise hs-TnT, NT-proBNP, hs-CRP, IL-6 and inflammatory biomarkers OPG, sRANKL, OPN and CCN1.
The safety objectives are:
To explore the effect of mTOR inhibition (everolimus) on several clinical and safety laboratory parameters including plasma lipid levels and blood count. This will be complemented by analysis of inflammatory cell subsets in coronary thrombi and peripheral blood (CD4+ T helper lymphocyte subsets, monocyte subsets).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Everolimus
Everolimus p.o. for 5 days (d0=7.5 mg, d1=7.5 mg, d2=7.5 mg, d3=5 mg, d4=5mg)
Everolimus
(d0=7.5 mg, d1=7.5 mg. d2=7.5 mg, d3=5 mg, d4=5mg)
Placebo
Placebo comparator with identical composition of tablets except everolimus
Placebo
matched placebo tablets manufactured to be identical to verum tablets except content of everolimus
Interventions
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Everolimus
(d0=7.5 mg, d1=7.5 mg. d2=7.5 mg, d3=5 mg, d4=5mg)
Placebo
matched placebo tablets manufactured to be identical to verum tablets except content of everolimus
Eligibility Criteria
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Inclusion Criteria
* ST-Elevation \> 1mm in \> 2 leads OR
* Novel left bundle branch block (LBBB) OR
* Posterior MI with ST-Depression \> 1mm in \> 2 leads
2. Chest pain duration of \> 10 minutes
3. Primary Coronary Intervention (PCI) with drug-eluting stent (DES) within 24 hours of chest pain onset in the occluded culprit artery
4. First Myocardial Infarction
5. Occluded coronary artery at angiography specifically occlusion of one coronary vessel in the proximal third of either LAD, RCX or RCA, the mid segment of right coronary artery (RCA) or mid segment of a large left anterior descending (LAD) coronary artery, i.e. when the latter reaches the apex.
6. Male and female patients 18 years to 90 years of age
7. Signed informed consent
Exclusion Criteria
2. Pregnant women or nursing mothers
3. Mechanical complication during acute coronary syndrome
4. Scheduled PCI for additional lesion within 30 days
5. Multivessel disease
6. Major elective surgery planned in trial period
7. Malignancy (unless healed or remission \> 5 years)
8. Chronic infection (HIV, Tbc, empyema)
9. Severely compromised renal function (GFR\< 30 ml/min)
10. Positive PCR Test for SARS-CoV-2 and/or at least one positive answer to questions regarding symptoms/contact related to COVID-19.
18 Years
90 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Novartis
INDUSTRY
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Frank Ruschitzka, Professor
Role: STUDY_DIRECTOR
UniversityHospitalZurich
Locations
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Kerckhoff-Klinik, Department of Cardiology
Bad Nauheim, , Germany
University Hospital Chartié
Berlin, , Germany
University Hospital Duesseldorf
Düsseldorf, , Germany
University Hospital Mainz
Mainz, , Germany
University Hospital Bern
Bern, , Switzerland
University Hospital Geneva
Geneva, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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Candreva A, Gotschy A MD PhD, Stehli J, Bissig L, Lodi Rizzini M, Chiastra C, Gallo D, Morbiducci U, Klingenberg R, Heg D, Matter CM, Ruschitzka F, Manka R, Stahli BE. Microcirculatory Resistance After Primary Percutaneous Coronary Intervention Predicts Residual Myocardial Damage and Scar Formation. J Am Heart Assoc. 2025 Feb 18;14(4):e036033. doi: 10.1161/JAHA.124.036033. Epub 2025 Feb 8.
Stahli BE, Klingenberg R, Heg D, Branca M, Manka R, Kapos I, Muggler O, Denegri A, Kesterke R, Berger F, Stehli J, Candreva A, von Eckardstein A, Carballo D, Hamm C, Landmesser U, Mach F, Moccetti T, Jung C, Kelm M, Munzel T, Pedrazzini G, Raber L, Windecker S, Templin C, Matter CM, Luscher TF, Ruschitzka F. Mammalian Target of Rapamycin Inhibition in Patients With ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2022 Nov 8;80(19):1802-1814. doi: 10.1016/j.jacc.2022.08.747. Epub 2022 Aug 29.
Klingenberg R, Stahli BE, Heg D, Denegri A, Manka R, Kapos I, von Eckardstein A, Carballo D, Hamm CW, Vietheer J, Rolf A, Landmesser U, Mach F, Moccetti T, Jung C, Kelm M, Munzel T, Pedrazzini G, Raber L, Windecker S, Matter CM, Ruschitzka F, Luscher TF. Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS) - A phase II, randomized, double-blind, multi-center, placebo-controlled trial. Am Heart J. 2022 May;247:33-41. doi: 10.1016/j.ahj.2022.01.010. Epub 2022 Jan 28.
Other Identifiers
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CLEVER-ACS
Identifier Type: -
Identifier Source: org_study_id