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Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI (C-STAR)

Primary Purpose

Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Evolocumab 140 MG/ML

Rosuvastatin 5mg

Ezetimibe 10mg

About this trial

This is an interventional treatment trial for Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia focused on measuring acute coronary syndrome, low-density-lipoprotein, PCSK9 inhibitor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Over 19 years old Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form. Patients who underwent percutaneous coronary stenting for acute coronary syndrome Exclusion Criteria: Patients who have previously taken statins, Patients with active liver disease or patients with three times or more increase in AST or ALT If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib, Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study The remaining life expectancy is expected to be less than a year. Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

Sites / Locations

Yongcheol KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evolocumab treatment group

Group not receiving evolocumab

Arm Description

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.

The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.

Outcomes

Primary Outcome Measures

Difference in LDL level change (mg/dL)

Difference in LDL level change between baseline and 2 weeks later in the test group and control group

Secondary Outcome Measures

Percent change in LDL level (%)

Percent change in LDL level at 2 weeks and 4 weeks later compared to baseline in the test group and control group

Presence or absence of side effects

Presence or absence of side effects (muscle pain, digestive disturbance, test abnormalities) after 2 weeks and 4 weeks of discharge compared to baseline in the test group and control group

HbA1c(%) level

HbA1c level at 4 weeks later compared to baseline in the test group and control group

Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level

Creatine kinase(CK) (IU/L)

Full Information

NCT ID

NCT05661552

First Posted

December 5, 2022

Last Updated

January 6, 2023

Sponsor

Yonsei University

Collaborators

Daewoong Pharmaceutical Co. LTD.

1. Study Identification

Unique Protocol Identification Number

NCT05661552

Brief Title

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

Acronym

C-STAR

Official Title

Effect of Early Initiation of Evolocumab and Combination Lipid-lowering Agent on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing percuTAneous coronaRy Intervention: a Prospective, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

December 15, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

Collaborators

Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Recently, studies have reported that strong LDL cholesterol lowering through PCSK9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. However, the LDL cholesterol reduction effect on statin is different from that of Westerners and Asians, and studies on the LDL cholesterol reduction effect of Koreans on the early use of PCSK9 inhibitors are insufficient. Therefore, we would like to study the effect of reducing LDL cholesterol by administering Evorukumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Keywords

acute coronary syndrome, low-density-lipoprotein, PCSK9 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

The experimental and control groups consist of patients undergoing stenting for acute coronary syndrome and will be randomized to receive early evolocumab along with statin/ezetimibe use or no evolocumab. Rosuvastatin 5 mg and Ezetimibe 10 mg are administered to both the experimental group and the control group.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Evolocumab treatment group

Arm Type

Experimental

Arm Description

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.

Arm Title

Group not receiving evolocumab

Arm Type

Active Comparator

Arm Description

The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.

Intervention Type

Drug

Intervention Name(s)

Evolocumab 140 MG/ML

Other Intervention Name(s)

REPATHA® (Amgen Inc, Thousand Oaks, California, USA)

Intervention Description

Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 5mg

Intervention Description

Rosuvastatin 5mg will be assigned to all participants

Intervention Type

Drug

Intervention Name(s)

Ezetimibe 10mg

Intervention Description

Ezetimibe 10mg will be assigned to all participants

Primary Outcome Measure Information:

Title

Difference in LDL level change (mg/dL)

Description

Difference in LDL level change between baseline and 2 weeks later in the test group and control group

Time Frame

Baseline, 2 weeks later

Secondary Outcome Measure Information:

Title

Percent change in LDL level (%)

Description

Percent change in LDL level at 2 weeks and 4 weeks later compared to baseline in the test group and control group

Time Frame

baseline, 2 weeks later 4 weeks later

Title

Presence or absence of side effects

Description

Presence or absence of side effects (muscle pain, digestive disturbance, test abnormalities) after 2 weeks and 4 weeks of discharge compared to baseline in the test group and control group

Time Frame

baseline, 2 weeks later 4 weeks later

Title

HbA1c(%) level

Description

HbA1c level at 4 weeks later compared to baseline in the test group and control group

Time Frame

4 weeks

Title

Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level

Time Frame

4 weeks

Title

Creatine kinase(CK) (IU/L)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongcheol Kim, MD, PhD

Phone

+823151898967

yongcheol@yuhs.ac

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Woong Roh, MD, PhD

Phone

+823151898792

NOMGALDA@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongcheol Kim, MD, PhD

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yongcheol Kim

City

Yongin

State/Province

Gyeonggi-do

ZIP/Postal Code

16995

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongcheol Kim, MD

Phone

+823151898967

yongcheol@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Yongcheol Kim, MD, PhD

First Name & Middle Initial & Last Name & Degree

Oh-Hyun Lee, MD

First Name & Middle Initial & Last Name & Degree

Ji Woong Roh, MD, PhD

First Name & Middle Initial & Last Name & Degree

Eui Im, MD

First Name & Middle Initial & Last Name & Degree

Deok-Kyu Cho, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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