Evolocumab in Patients With Acute MI

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04082442
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.
  • Placebos — DRUG
    Matching placebo.

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 patients with an ACS by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

Key Dates

Start date
Sep 1, 2019
Status verified
Oct 2025
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024

Study Design

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

Arms

  • Experimental: Evolocumab
    420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously using an autoinjector/pen in ACS patients .

Primary Outcome Measure

Change in LDL-Cholesterol [ Time Frame: Baseline, 25-30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Johns Hopkins HospitalBaltimoreMaryland21287-

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By research site
The Johns Hopkins Hospital· Baltimore, MD

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