2026-04-12
notable
Study Status, Study Design v5
Phase changed: Phase 2 → Early Phase 1
2026-04-07
minor
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, IPDSharing v4
Primary completion date2026-06-30→2026-10-30
Completion date2026-06-30→2026-10-30
Enrollment target30→18
Eligibility criteria+357 characters
Inclusion Criteria:
AgedFully betweencomprehend 18the purpose, characteristics, methodology, and 75potential yearsadverse old,reactions maleof orthis femalestudy;
Patients withvoluntarily recentparticipate (withinin 30the daysresearch and sign an informed consent form prior to enrollment)any whorelated haveassessments;
Male hador female subjects aged ≥18 years and ≤75 years;
Clinically diagnosed with acute coronary syndrome;
CTA examination(ACS) of(including acute myocardial infarction or unstable angina) and meeting the presencefollowing ofcriteria:
① atPatients with ≥30% and <70% stenosis in [...] [...]
Primary endpoints1 entry, revised
TheAssessment changeof changes in coronary artery low-attenuatedattenuation plaque volume (LAPV) offrom thebaseline targetat vessel6 segmentmonths ofafter thetreatment based on coronary arterycomputed was assessed by CTtomography angiography (CTACCTA).
Study title+10 characters
A Clinical Study Evaluating the Stability and Efficacy of IMC-001 for Injection onin Improving Atherosclerotic PlaquesPlaque Stability in Patients With ACSAcute Coronary Syndrome.
2025-11-27
minor
Study Status, Study Description, Arms and Interventions v3
Re-verified, no change to tracked fields
2025-08-19
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2025-11-30→2026-06-30
Completion date2025-12-30→2026-06-30
Enrollment target14→30
InterventionsIMC-001 (Drug), Optimal medical treatment (Drug), Optimal medical treatment (Drug)→IMC-001 and Optimal medical treatment (Drug), IMC-001 placebo and optimal medical treatment (Drug)
Eligibility criteria+59 characters
[...] y attenuated plaques (LAP) that meet the definition of CTA;
High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L;
Subjects should take effective contraceptive measures to avoid pregnancy or impregnation of their partner during the period of taking the study drug until 6 months after stopping the drug;
Subjects understand and comply with the study proceduresprocess, participate voluntarily, and sign the informed consent form..
Exclusion Criteria:
Subjects who meet any of the following [...] r this study:
Those who have had cerebral infarction or TIA inwithin the past 12 months.
Myocardial infarction [...] [...]
Study sitesdetails revised at 1 of 2 sites
Collaborators3 entries, reordered
Study title+37 characters
A Study Evaluating the Stability and Efficacy of IMC-001 for Injection on Improved Atherosclerotic Plaque StabilityPlaques in Patients ofWith ACS.
2025-06-10
notable
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-19→confirmed 2025-03-10
Study sites0→2
Eligibility criteria+3,212 characters
[...] meet any of the following criteria cannot enter this study:
CTA shows complete occlusion of any section of blood vessel.
Those who have had cerebral infarction or TIA in the past 12 months.
Myocardial infarction within the past 12 months (excluding acute myocardial infarction occurred within 1 month before this dose).
Patients who have received CABG, heart transplantation, SA [...] . during the study.
Recurrent episodes, severe symptoms, and cardiac arrhythmias that do not respond to drug therapy within the [...] tricular rate, and paroxysmal supraventricular tachycardia.
ECG showing prolonged QT interval, [...] [...]
Collaborators2 to 3 entries
RenJi Hospital