RecruitingPhase 2NCT05472337
Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
Sponsor
Pontificia Universidad Catolica de Chile
Enrollment
50 participants
Start Date
Aug 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age ≥18 years.
- Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as:
- \- Presence of chest pain, associated with enzymatic elevation (increase of ultrasensitive troponin above normal value (99th percentile)) with or without electrocardiographic changes.
- Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
- Ability and willingness to provide written informed consent.
Exclusion Criteria7
- ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine).
- Severe left main stenosis.
- Advanced heart failure, left ventricular ejection fraction <35%.
- Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
- Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular filtration rate (MDRD), use of CYP3A4 or calcineurin inhibitors, active autoimmune disease or the use of chronic anti-inflammatory therapy, concomitant infection, pregnancy or concomitant infection, pregnancy or lactation.
- Any other disease that limits life expectancy to <1 year.
- Medical history of a disorder that could, in the opinion of the treating physician, place the participant at significant risk if they were to participate in the trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGColchicine
Oral colchicine (1 mg loading dose followed by 0.5 mg 1 hour later, administered 6 to 24 hours before angioplasty, followed by 0.5 mg (1 comp.) per day for 6 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05472337
Related Trials
A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography
NCT072308471 location
Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome
NCT064419424 locations
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
NCT0710262852 locations
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
NCT013113237 locations
MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
NCT065430829 locations