Colchicine

This study aims to investigate whether TET2-associated clonal hematopoiesis of indeterminate potential (TET2-CHIP) can serve as a biomarker to guide precision use of colchicine in a population of clinically stable post-ACS patients receiving standard of care (SoC) therapy. Specifically, we will evaluate whether TET2-CHIP status predicts a differential response to colchicine. As a pilot study, it also aims to provide detailed data supporting design of further trial, such as sample size calculating, endpoint optimizing, etc.

This is a single-center, prospective, randomized, open-label, assessor-blinded, blank-controlled exploratory (pilot) trial evaluating the feasibility of oral colchicine after coronary artery bypass grafting (CABG). Graft failure and cardiovascular events remain common after CABG, and the anti-inflammatory drug colchicine has shown cardiovascular benefit in chronic coronary disease but has not been adequately studied after CABG. Approximately 100 adults (aged 18 years and older, any sex) who have undergone first-time isolated CABG, are clinically stable within 3 days after surgery, and are able to take oral medications will be enrolled. Participants will be randomized 1:1 to receive oral colchicine 0.5 mg once daily, initiated within 3 days after surgery and continued for up to 1 year, or no colchicine (blank control). The primary objective is to assess the feasibility of oral colchicine after CABG, including participant recruitment rate, informed consent rate, treatment adherence, 1-year follow-up completion rate (coronary CT angiography review rate), and safety acceptability, to provide feasibility evidence and sample size estimation parameters for a future multicenter confirmatory randomized controlled trial. Secondary and exploratory objectives include preliminary comparisons of 1-year graft failure (Fitzgibbon B/S/O grades), major adverse cardiovascular events (MACE-5), serious complications of interest, new-onset perioperative atrial fibrillation/flutter, changes in high-sensitivity C-reactive protein and neutrophil-to-lymphocyte ratio, and the incidence of diarrhea and serious infection. Each participant will be followed for 1 year after surgery.

Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors. The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.

Colchicine is an inexpensive drug that has been available for decades. Trials, which excluded patients with kidney disease, showed that colchicine decreased the number of heart attacks and strokes. The investigators cannot be sure if these results will apply to dialysis patients and a clinical trial exploring the effect of colchicine on heart attacks and strokes specifically in dialysis patients is needed. Colchicine may also be beneficial for dialysis patients as it may help arteriovenous fistulas to last longer. An arteriovenous fistula is a connection made between an artery and a vein in the arm, allowing for access to a person's bloodstream as part of dialysis. Sometimes, these connections can get too narrow in some parts, stopping them from working properly. These narrowings can be treated with a balloon inserted into the vein with the help of an x-ray. Balloons coated with a drug called paclitaxel, which works like colchicine, can be helpful, so the investigators think colchicine may help too. At present, colchicine is often avoided in patients receiving dialysis. Patients on haemodialysis take a number of medications already and have significant comorbidity. Therefore, it is possible that a higher proportion would have difficulty tolerating colchicine. These concerns mean that a large trial assessing the potential benefits of colchicine in this population cannot begin without further data on feasibility. This feasibility study will establish whether low dose colchicine is tolerated and acceptable to dialysis patients and will help the investigators to plan recruitment to future clinical trials. The investigators will give colchicine to 100 dialysis patients. The investigators will monitor the participants for side effects and see how many continue to take it for the planned period of 3 months. If feasibility is confirmed, there are then strong rationales for large clinical trials exploring the effect of colchicine on both mortality and vascular access outcomes in dialysis patients.

This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.

This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.

This trial is designed to evaluate whether low-dose colchicine, in addition to standard treatment recommended by guidelines, further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.

The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.