- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515304
Evolocumab in Acute Coronary Syndrome (EVACS)
Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in NSTEMI patients (1) decreases LDL-C during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by Positron Emission Tomography (PET) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months.
This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population. It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21136
- Steven Paul Schulman
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Non ST segment elevation myocardial infarction
- Troponin I >/ 5.0 ng/dL
- Permission of attending physician
Exclusion Criteria:
- ST elevation myocardial infarction
- Patients requiring invasive hemodynamic support
- Scheduled for cardiac surgery
- Current or prior treatment with a PCSK9 antibody
- Current participation in an intervention clinical trial
- Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
- Contraindication to statin therapy
- Subject likely not able to complete protocol related visits or procedures
- Latex allergy
- History of hypersensitivity to any monoclonal antibody
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evolocumab
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
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420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Other Names:
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Placebo Comparator: Placebo
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
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Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in LDL-Cholesterol
Time Frame: 30 days
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The mean percent change from baseline in LDL-C comparing placebo and evolocumab groups at 30 days
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30 days
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PET Imaging for inflammation
Time Frame: 30 days.
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Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium, aorta and / or carotid artery between the two treatment groups.
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30 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in left ventricular volume as assessed by echocardiography
Time Frame: Baseline, day 30 and 6 months
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Evaluation of left ventricular volume (ml) by echocardiography
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Baseline, day 30 and 6 months
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Change in ejection fraction as assessed by echocardiography
Time Frame: Baseline, day 30 and 6 months
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Evaluation of ejection fraction (%) by echocardiography
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Baseline, day 30 and 6 months
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Change in plasma proprotein convertase subtilisin kexin-9 (PCSK9) levels (ng/ml)
Time Frame: Baseline, day 30 and 6 months
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Change from baseline in PCSK9 serum levels
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Baseline, day 30 and 6 months
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Change in plasma soluble lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1)
Time Frame: Baseline, day 30 and 6 months
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Change from baseline in plasma soluble lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) (pg/ml)
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Baseline, day 30 and 6 months
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PET-FDG assessed vascular inflammation
Time Frame: Baseline and day 30
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Target artery to background ratio endpoint [standardized uptake value] for carotid artery or aorta
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Baseline and day 30
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Change in New York Heart Association (NYHA) Class
Time Frame: Baseline, day 30 and 6 months
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Assess NYHA class I-IV
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Baseline, day 30 and 6 months
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Change in high sensitivity C-reactive protein (hs-CRP) serum levels
Time Frame: Baseline, day 30 and 6 months
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Change from baseline in hs-CRP serum levels (mg/L)
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Baseline, day 30 and 6 months
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Change in tumor necrosis factor (TNF)-alpha serum levels
Time Frame: Baseline, day 30 and 6 months
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Change from baseline in TNF-alpha serum levels (pg/mL)
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Baseline, day 30 and 6 months
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Change in plasma levels of Interleukin 1
Time Frame: Baseline, day 30 and 6 months
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Change from baseline in serum levels of Interleukin 1 (pg/mL)
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Baseline, day 30 and 6 months
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Change in serum levels of Interleukin 6
Time Frame: Baseline, day 30 and 6 months
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Change in baseline in serum levels of Interleukin 6 (pg/mL)
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Baseline, day 30 and 6 months
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Change in serum levels of Interleukin 10
Time Frame: Baseline, day 30 and 6 months
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Change in baseline in serum levels of Interleukin 10 (pg/mL)
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Baseline, day 30 and 6 months
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Change in Canadian Angina Class
Time Frame: Baseline, 30 days, 6 months
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Assess Canadian Angina Classification, I-IV
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Baseline, 30 days, 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thorsten M Leucker, MD, PhD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Protease Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Serine Proteinase Inhibitors
- PCSK9 Inhibitors
- Evolocumab
Other Study ID Numbers
- IRB00156313
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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