Efficacy of CONservative versus invasive therapy in acute Coronary syndrome with plaque Erosion PhenoType - the CONCEPT-ACS trial

Phase 1

• Conditions: patients affected by acute coronary syndrome with plaque erosion phenotype; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2023-000123-37-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-06
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

•Age >= 18 years;
•Admission with acute coronary syndrome (unstable angina, NSTEMI and STEMI);
•A residual vessel diameter stenosis of less than 70% and Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 after wiring of the culprit vessel (and thrombus aspiration, if needed);
•A diagnosis of plaque erosion by intracoronary OCT imaging of the culprit vessel, with a residual area stenosis <60% and minimum lumen area >3.5 mm2.
•Signed written informed consent to study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

•Age <18 years old;
•Left ventricular ejection fraction (LVEF) < 30%;
•Hypotension, shock, or need for mechanical circulatory support or intravenous vasopressors;
•Contraindication or known hypersensitivity to any of the study drugs (i.e., aspirin, ticagrelor, heparin, and/or colchicine);
•Unstable ventricular arrhythmias;
•Creatinine clearance < 30 ml/min/1.73 m2 (as calculated by MDRD);
•Severe vessel tortuosity or calcification of the culprit vessel, such that it is unlikely that the OCT catheter can be delivered.
•The culprit lesion is a stent thrombosis;
•Life expectancy < 1 year;
•Known history of systemic inflammatory conditions and/or current use or plans to begin chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids are allowed);
•History of cancer or lymphoproliferative disease within the last 3 years.
•Refusal to sign the written informed consent to study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified