None listed
Conditions
Brief summary
While the ability to effectively prevent cardiovascular disease (CVD) in the elderly is imperative, there are few primary prevention therapies. The gout medicine colchicine inhibits the critical pathways of inflammation and platelet activation involved in atherothrombosis, but does not increase bleeding. Colchicine has a broad anti-inflammatory effect. Benefits of long-term low-dose colchicine have been confirmed in people with established coronary artery disease, with a substantial 31% (95%CI 22-40%) reduction in cardiovascular events. We have demonstrated that older people have a distinctive platelet phenotype of increased basal activation, hyperreactivity to adenosine diphosphate and thrombin resistance, correlating with elevated inflammation. Thrombin generation associated with systemic inflammation was identified as a possible novel target to prevent CVD in the elderly. A small pilot trial will be used to assess the effectiveness and safety of colchicine compared to usual care in inhibiting platelet activation and inflammation in elderly patients without cardiovascular disease.
Interventions
Oral tablet of colchicine (500 mcg daily or twice daily) for four weeks post enrolment
Adherence will be monitored by drug return.
Sponsors
Concord Hospital Cardiology Department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• People aged >= 70yrs not on medication or comorbidities affecting platelet function. • Able to provide signed informed consent. • Willingness to participate and comply with the study requirements.
Exclusion criteria
• Medications and comorbidities affecting platelet function: on antiplatelet agent, anticoagulation, non steroid anti-inflammatory drugs (within 7 days), fish oil supplements (within 7 days), acute myocardial infarction, past cardiovascular disease, pulmonary embolism, active cancer, active sepsis or bleeding/clotting disorders. • Definite indication for colchicine, such as acute gout or acute pericarditis • Contraindication to colchicine, including: • Hypersensitivity • Currently taking or might need during the trial, a concomitant treatment which is contraindicated with colchicine: cyclosporin, strong CYP3A4 inhibitors, phenylbutazone, immunosuppressants and anti-neoplastic agents. • Current/history of inflammatory bowel disease, chronic diarrhea, blood dyscrasias or eGFR<15mL/min/1.73m2. • Current surgical or medical conditions that might significantly alter the absorption, distribution, metabolism, or excretion of trial drugs such as prior major gastrointestinal tract surgery (e.g. gastrectomy, lap band, or bowel resection) • History of alcohol or drug abuse within 12 months. • Resident of aged care facility or significant cognitive impairment precluding consent
Outcome results
None listed