Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population

NCT06096909 | Not Yet Recruiting DMC

• 1 other identifier: 2021-CXGC03-002
• Study Type: interventional
• Target: 3,684
• Locations: 0 countries
• Sites: N/A

Brief Summary

For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.

Conditions

Acute Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  Including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, and coronary revascularization). The coronary revascularization includes coronary intervention (PCI), coronary artery bypass grafting (CABG).

  at the end of 2 years

Secondary Outcomes (2)

• major adverse cardiovascular events (MACEs)

  at the end of 6 months

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  at the end of 1 years

Other Outcomes (5)

• Additional observed endpoint 1

  at the end of 2 years

• Additional observed endpoint 2

  at the end of 2 years

• Additional observed endpoint 3

  at the end of 2 years

Study Arms (2)

experimental group

EXPERIMENTAL

intensive lipid lowering therapy

Drug: Tafolecimab; Drug: Statin

control group

ACTIVE COMPARATOR

conventional lipid lowering therapy

Drug: Cholesterol Absorption Inhibitor; Drug: Statin

Interventions

Tafolecimab DRUG

The PCSK9 mAb in this study is defined as Tafolecimab 150mg q2w subcutaneously. For the two groups of lipid-lowering regimens, the lipid-lowering drug regimens other than PCSK9 mAb were maintained throughout the study as much as possible in accordance with the guidelines related to blood lipids, provided that no serious safety problems occurred.

experimental group

Cholesterol Absorption Inhibitor DRUG

Cholesterol absorption inhibitors (like Ezetimibe and Hybutimibe) are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Ezetimibe 10mg Po qd.

control group

Statin DRUG

Statin are based on physician decisions, but need to be routinely dosed. Examples of Medications that Meet Study Requirements: Atorvastatin 20mg Po qn, Rosuvastatin 10mg Po qn or Pitavastatin 4mg Po qn.

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 75 years;
• clinical diagnosis with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) ;
• undergoing PCI
• baseline LDL-C 1.8 mmol/L 3.4 mmol/L note: NSTE-ACS includes non-ST-elevation myocardial infarction and unstable angina.

You may not qualify if:

• Severe heart failure (Killip III or IV) or cardiogenic shock;
• Previous hemorrhagic cerebrovascular disease history;
• Uncontrolled or recurrent arrhythmic events;
• poorly controlled hypertension;
• Severe hepatic and renal insufficiency (ALT/AST\> 3 times upper limit of normal, eGFR\<30 ml/kg/1.73m2, or ongoing dialysis) or creatine kinase elevation\>5 times upper limit of normal
• malignant tumor;
• Intolerance to statins or cholesterol absorption inhibitors;
• Intolerance to injections;
• Life expectancy \<1 year;
• poor compliance.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Innovent Biologics, Inc.: collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 24, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 24, 2023

Record last verified: 2023-10