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Controlled Level EVERolimus in Acute Coronary Syndromes (CLEVER-ACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Zurich
Sponsor:
Collaborators:
Swiss National Science Foundation
Novartis
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01529554
First received: February 3, 2012
Last updated: May 21, 2014
Last verified: May 2014

February 3, 2012
May 21, 2014
May 2014
October 2015   (final data collection date for primary outcome measure)
Myocardial infarct size measured by MRI [ Time Frame: Change from baseline at 30 days ] [ Designated as safety issue: No ]
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 12-48h (baseline) and 30 days
Same as current
Complete list of historical versions of study NCT01529554 on ClinicalTrials.gov Archive Site
Microvascular obstruction (MVO) measured by MRI [ Time Frame: Change from baseline at 30 days ] [ Designated as safety issue: No ]
To evaluate microvascular obstruction (MVO) by MRI at 12-48 h (baseline) and 30 days
Same as current
Not Provided
Not Provided
 
Controlled Level EVERolimus in Acute Coronary Syndromes
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

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 measured by MRI (Late Gadolinium Enhancement for transmurality) at 12-48h (baseline) and 30 days
  2. (2° endpoint): To evaluate microvascular obstruction (MVO) as change from baseline measured by MRI at 12-48 h (baseline) and 30 days
  3. (3° endpoints):

    1. To determine the effect of mTOR inhibition (everolimus) as change from baseline on the classic biomarkers hsTnT, NT-proBNP, hs-CRP and IL-6 at 30 days compared to 12-48 h (baseline) and time-course (AUC)
    2. To evaluate the effect of mTOR inhibition (everolimus) on the inflammatory biomarkers as change from baseline for OPG, sRANKL, OPN at 30 days compared to 12-48 h (baseline) and time-course (AUC)
    3. Left ventricular volumes evaluated by MRI

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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndromes
  • Drug: Everolimus
    (d0=7.5 mg, d1=7.5 mg. d2=7.5 mg, d3=5 mg, d4=5mg)
  • Drug: Placebo
    matched placebo tablets manufactured to be identical to verum tablets except content of everolimus
  • Active Comparator: Everolimus
    Everolimus p.o. for 5 days (d0=7.5 mg, d1=7.5 mg, d2=7.5 mg, d3=5 mg, d4=5mg)
    Intervention: Drug: Everolimus
  • Placebo Comparator: Placebo
    Placebo comparator with identical composition of tablets except everolimus
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients who enter the hospital with the main diagnosis of Acute Coronary Syndrome (STEMI) as defined by:

  1. 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) within 24 hours of chest pain onset
  4. Age > 18 years
  5. Signed informed consent

Exclusion Criteria:

  1. Participation in another drug or stent trial
  2. Pregnant women or nursing mothers
  3. Mechanical complication during acute coronary syndrome
  4. Major elective surgery planned in study period
  5. No informed consent
  6. Malignancy (unless healed or remission > 5 years)
  7. Chronic infection (HIV, Tbc, empyema)
  8. Severely compromised renal function (GFR< 30 ml/min)
Both
18 Years to 90 Years
No
Contact: Roland Klingenberg, MD 0041 44 255 ext 1111 roland.klingenberg@usz.ch
Switzerland
 
NCT01529554
CLEVER-ACS
Yes
University of Zurich
University of Zurich
  • Swiss National Science Foundation
  • Novartis
Study Chair: Thomas F Lüscher, Professor Dept. Cardiology, University Hospital Zurich
Study Director: Roland Klingenberg, MD Dept. of Cardiology, University Hospital Zurich
University of Zurich
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP