Evolocumab in Acute Coronary Syndrome

• Status: Active, not recruiting
• Trial end date: 2022-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Amgen; Washington University School of Medicine
• Treatments: Antibodies, Monoclonal; Evolocumab

Criteria

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