Controlled Level EVERolimus in Acute Coronary Syndromes

• Register: ClinicalTrials.gov
• Last refreshed on: 13 December 2021
• Main ID: NCT01529554
• Date of registration: 03/02/2012
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Controlled Level EVERolimus in Acute Coronary Syndromes CLEVER-ACS
• Scientific 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
• Date of first enrolment: January 8, 2015
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01529554
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Frank Ruschitzka, Professor
• Affiliation: UniversityHospitalZurich

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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

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:

1. Participation in another drug or stent trial

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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Coronary Syndromes

Intervention(s)

Drug: Everolimus

Drug: Placebo

Primary Outcome(s)

Myocardial infarct size measured by MRI [Time Frame: Change from baseline at 30 days]

Secondary Outcome(s)

Microvascular obstruction (MVO) measured by MRI [Time Frame: Change from baseline at 30 days]

Secondary ID(s)

CLEVER-ACS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss National Science Foundation

Novartis