Evolocumab in Acute Coronary Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03515304
Phase
PHASE2
Status
Completed

Conditions

  • Acute Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
25 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
  • Placebo — DRUG
    Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.

Study Details

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 Dates

Start date
May 20, 2018
Status verified
Apr 2026
Primary completion
Oct 25, 2024
Completion
Mar 25, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.

Primary Outcome Measure

Percent Change in LDL-Cholesterol [ Time Frame: Baseline to 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Steven Paul SchulmanBaltimoreMaryland21136-

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