The effect of repurposing low-dose colchicine in older populations on platelet activation and inflammation (CO-OPERATE): A pilot trial.

Phase 4

Recruiting

• Conditions: Ageing; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12622000585729
• Lead Sponsor: Concord Hospital Cardiology Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-20
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood sample to assess change in platelet function with stimulation (aggregometry using agonists - adenosine diphosphate (ADP), thrombin and collagen) [composite][ Baseline, 4 weeks post intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Blood samples assessing surface markers of platelet activation under resting conditions [ Baseline, 4 weeks post intervention commencement];Blood samples assessing change in coagulation markers (INR, APTT, PT)<br>[ Baseline, 4 weeks post intervention commencement];Adverse effects: nausea, vomiting, abdominal pain, diarrhoea using the Common Terminology Criteria for Adverse Events (CTCAE5.0)[ Baseline, 4 weeks post intervention commencement];Blood samples assessing surface markers of platelet activation post stimulation with agonists [ Baseline, 4 weeks post intervention commencement];Blood samples assessing D-Dimer[ Baseline, 4 weeks post intervention commencement];Blood samples assessing inflammatory markers (CRP, IL6, IL1-beta, TNF-alpha)[ Baseline, 4 weeks post intervention commencement]; Adherence (pill count)[ 4 weeks post commencement of intervention]