Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI

Conditions

• Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Evolocumab 140 MG/ML — DRUG
  Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe
• Rosuvastatin 5mg — DRUG
  Rosuvastatin 5mg will be assigned to all participants
• Ezetimibe 10mg — DRUG
  Ezetimibe 10mg will be assigned to all participants

Study Details

Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI

Key Dates

Start date

Dec 1, 2022

Status verified

Mar 2025

Primary completion

Feb 5, 2025

Completion

Feb 5, 2025

Study Design

Enrollment

108 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Evolocumab treatment group
  The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period.
• Active Comparator: Group not receiving evolocumab
  The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.

Primary Outcome Measure

Percent change in LDL level (%) [ Time Frame: Baseline, 2 weeks later ]