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OpenTrials
Completed

NCT Number: NCT01529554

Controlled Level EVERolimus in Acute Coronary Syndromes

Acute myocardial infarction (AMI) constitutes the major cause of death in most nations and death rates and morbidity remain substantial in the years thereafter. Inflammation is a hallmark throughout the distinct stages of atherosclerotic lesion formation preceding AMI as well as at the time of plaque rupture and during the post-infarct repair phase. Harnessing its harmful consequences constitutes an attractive therapeutic approach to address this unmet medical need.

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).

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Inflammation Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kerckhoff-Klinik, Department of Cardiology, Bad Nauheim, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevation Myocardial Infarction (STEMI) as defined by:
  • ST-Elevation > 1mm in > 2 leads OR
  • Novel left bundle branch block (LBBB) OR
  • Posterior MI with ST-Depression > 1mm in > 2 leads
  • Chest pain duration of > 10 minutes
  • Primary Coronary Intervention (PCI) with drug-eluting stent (DES) within 24 hours of chest pain onset in the occluded culprit artery
  • First Myocardial Infarction
  • 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.
  • Male and female patients 18 years to 90 years of age
  • Signed informed consent

Exclusion criteria

  • Participation in another drug or stent trial
  • Pregnant women or nursing mothers
  • Mechanical complication during acute coronary syndrome
  • Scheduled PCI for additional lesion within 30 days
  • Multivessel disease
  • Major elective surgery planned in trial period
  • Malignancy (unless healed or remission > 5 years)
  • Chronic infection (HIV, Tbc, empyema)
  • Severely compromised renal function (GFR< 30 ml/min)
  • Positive PCR Test for SARS-CoV-2 and/or at least one positive answer to questions regarding symptoms/contact related to COVID-19.

Treatment and study plan

Everolimus

Drug

(d0=7.5 mg, d1=7.5 mg. d2=7.5 mg, d3=5 mg, d4=5mg)

Placebo

Drug

matched placebo tablets manufactured to be identical to verum tablets except content of everolimus

Primary outcomes

  1. Myocardial infarct size measured by MRI

    Time frame: Change from baseline at 30 days

    To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as measured by MRI (Late Gadolinium Enhancement (LGE) for infarct size (transmurality) at 12-72 h (baseline) and 30 days

Secondary outcomes

  1. Microvascular obstruction (MVO) measured by MRI

    Time frame: Change from baseline at 30 days

    To evaluate microvascular obstruction (MVO) by MRI at 12-72 h (baseline) and 30 days

Other outcomes

  1. Left ventricular volume measured by MRI

    Time frame: Change from baseline at 30 days

    To evaluate left ventricular volume by MRI at 12-72 h (baseline) and 30 days

  2. Biomarkers

    Time frame: Change from baseline at 30 days including time course

    To evaluate the changes of left ventricular volume from baseline

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Novartis
  • Swiss National Science Foundation

Registry information

Official study title

Phase I-II Randomized Prospective Double-blind Multi-center Trial on the Effects of a Short Course of Oral Everolimus on Infarct Size, Left Ventricular Remodeling and Inflammation in Patients With Acute ST-Elevation Myocardial Infarction

Acronym: CLEVER-ACS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2012
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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