Evolocumab in Acute Coronary Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

Key facts

Study ID

NCT03515304

Run by

Johns Hopkins University

People needed

60

Starts

2018-05-20

Expected to finish

2025-03-25

Last updated by the study team

2026-05-01

Who can join

Age: 25 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non ST segment elevation myocardial infarction
• Troponin I >/ 5.0 ng/dL
• Permission of attending physician

You may not qualify if…

• 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

Where it is running

• Steven Paul Schulman — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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