A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS

Phase 2

Not yet recruiting

• Conditions: Atherosclerosis
• Interventions: Drug: IMC-001; Drug: Optimal medical treatment

• Registration Number: NCT06788431
• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Brief Summary

This study is an IIT clinical study to evaluate the efficacy and safety of IMC-001 for injection on improved atherosclerotic plaque stability in patients receiving optimal medical therapy after a recent acute coronary syndrome (ACS). The study was a single-center, simple randomized, controlled study, in which the experimental group was given IMC-001 and the best drug treatment, and 8 subjects were included, and the control group was given only the best drug treatment, and 6 subjects were included.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-02-19
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Aged between 18 and 75 years old, male or female;
2. Patients with recent (within 30 days prior to enrollment) who have had acute coronary syndrome;
3. CTA examination of the presence of at least one measurable target vessel segment in the coronary artery, and the following two conditions must be met at the same time: the total volume of plaques with calcified volume accounting for <50%, and the presence of low-density attenuated plaques (LAP) that meet the definition of CTA;
4. Subjects understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.

Exclusion Criteria

Subjects who meet any of the following criteria cannot enter this study:

1. CTA shows complete occlusion of any section of blood vessel.
2. Those who have had cerebral infarction or TIA in the past 12 months.
3. Myocardial infarction within the past 12 months.
4. Patients who have received CABG, heart transplantation, SAVR/TAVR, etc. (patients who have undergone PCI in the past can be included); or patients who plan to undergo treatment such as CABG, PCI, heart transplantation, SAVR/TAVR, etc. during the study.
5. Recurrent episodes, severe symptoms, and cardiac arrhythmias that do not respond to drug therapy within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate, and paroxysmal supraventricular tachycardia.
6. Subjects who, in the opinion of the investigator, are not suitable to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMC-001 and Optimal medical treatment	Optimal medical treatment	-
Optimal medical treatment	Optimal medical treatment	-
IMC-001 and Optimal medical treatment	IMC-001	-

Primary Outcome Measures

Name	Time	Method
The change in low-attenuated plaque volume (LAPV) of the target vessel segment of the coronary artery was assessed by CT angiography (CTA).	Day 29、Day 57、Day 85、Day 168