PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population

Acute Coronary Syndrome Clinical Trial

Official title:

Effect of PCSK9 Inhibitor on Acute Coronary Syndrome Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population (CHOICE Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05043740
• Other study ID #: CHOICE202101
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2021
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is an open-label, multicenter, and randomized study. The objective of this study is to demonstrate the effect of PCSK9 inhibitor on ACS patients with multivessel disease and relatively low LDL-C levels or LDL-C levels lower than the recommended target. The primary outcome was the rate of major adverse cardiac events (CV death, non-fatal myocardial infarction, documented unstable angina that requires admission into a hospital, all coronary revascularization with either PCI or CABG occurring at least 30 days after randomization, Non-fatal stroke) at 1 year. The secondary efficacy endpoints were individual components of the major adverse cardiac events, all cause death, and the percent change in LDL-C, Apo B, HDL-C, Lp(a) after treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1360
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 40-85 years age;
• Recent hospitalization for acute coronary syndrome
• LDL-C =70 mg/dL (=1.8 mmol/L) in patients who have been receiving stable treatment with moderate- or high-intensity statin within = 4 weeks prior to enrollment (i.e. continuous treatment that has not changed with regard to statin intensity over the past 4 weeks) or, LDL-C =90 mg/dL (=2.3 mmol/L) in patients who have been receiving stable treatment with low-intensity statin within = 4 weeks prior to enrollment (i.e. continuous treatment that has not changed with regard to statin intensity over the past 4 weeks), or LDL-C=125 mg/dL (=3.2 mmol/L) in patients who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment;
• Multivessel disease, defined as =50% reduction in lumen diameter of at least three major epicardial coronary arteries by angiographic visual estimation or in major branches of one or more of these arteries, irrespective of the localization (proximal 50mm or more distal localization) of the obstructive lesions
• Patients with written informed consent.

Exclusion Criteria:

• Unstable clinical status (hemodynamic or electrical instability); Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening;
• Severe renal dysfunction, defined by estimated glomerular filtration rate <30 ml/min/1.73m2;
• Active liver disease or hepatic dysfunction, either reported in patient medical record or defined by asparate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3x the upper limit of normal;
• Patients who previously received evolocumab or other PCSK9 inhibitor;
• Treatment with systemic steroids or systemic cyclosporine in the past 3 months systemic cyclosporine, systemic steroids (eg. intravenous, intramuscular or per os);
• Known active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator;
• Patients who will not be available for study-required procedures in the judgment of the Investigator;
• Current enrollment in another investigational device or drug study;
• Active malignancy requiring treatment;
• Intolerance of or allergy to statin or PCSK9 inhibitor;
• pregnancy, giving birth within the last 90 days, or lactation.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Repatha or Praluent
Evolocumab (Repatha®) 140 mg or Alirocumab (Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	The primary endpoint in the CHOICE study was the rate of major adverse cardiac events at 1 year. The definition of major adverse cardiac events was a composite of: CV death; Major coronary events 1) non-fatal myocardial infarction [MI]; 2)documented unstable angina that requires admission into a hospital; 3)all coronary revascularization with either PCI or CABG occurring at least 30 days after randomization); Non-fatal stroke	12 months
Secondary	Secondary Endpoint	The secondary efficacy endpoints were individual components of the major adverse cardiac events, all cause death, and the percent change in LDL-C, Apo B, HDL-C, Lp(a) at 1 year.	12 months
Secondary	Secondary Endpoint	the percent change in LDL-C, Apo B, HDL-C, Lp(a) at 1 year.	12 months