drugset / Trial / NCT03515304

Evolocumab in Acute Coronary Syndrome

NCT03515304

Phase 2 Completed 60 enrolled Johns Hopkins University Amgen · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2018-05-20
Primary completion
2024-10-25
Completion
2025-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 420 mg Subcutaneous