The LoDoCo Trial: The effect of low dose colchicine on the natural history of patients with stable coronary artery disease

Phase 3

Completed

• Conditions: Coronary artery disease; Acute ischemic coronary events; Acute ischemic cerebrovascular events; Cardiovascular - Coronary heart disease; Stroke - Ischaemic

• Registration Number: ACTRN12610000293066
• Lead Sponsor: Mark Nidorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

Angiographic proof of coronary disease
Clinically stable for >6months
Coronary Artery Bypass Grafting [CABG] more than 10 years ago or CABG at any time if the patient had subesquently had recurrent angina and angiographic evidence of blocked grafts or progressive native coronary disease requiring intervention with angioplasty
Willing to be randomised
Likely to be compliant

Exclusion Criteria

Any clinically significant co-morbidity
Clinical instability within prior 6 months CABG<10 years ago unless intervention has been required
Unwilling to enrole or uncertainty re compliance
Already on long-term colchicine for unrelated condition
Known sensitivity to colchicine
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of: Major Adverse Cardiac or Cerebrovascular Events [MACCE] including [a] Acute coronary sydromes as evidenced by a history of ischemic chest pain, changes in the electrocardiogram and a rise in serum Troponin above the normal range [b] Unstable [new or worsening] angina associated with a documented change in coronary anatomy as evidenced by repeat angiography [c] Sudden Cardiac Death as evidenced by the death certificate or non-fatal out of hospital cardiac arrest [d] New [documented] stroke unrelated to atrial fibrillation or intra-cranial hemorrhage as evidenced by a diagnostic change on cerebral tomography [CT] or magnetic resonant imaging [MRI] of the brain AND after review of the patient and all relevant data by an independent specialist neurologist][The final analysis will occur once the last patient enrolled to the study has been followed for 2 years.]

Secondary Outcome Measures

Name	Time	Method
Tolerability to therapy as evidenced by the patients self reporting of side-effects and willingness to continue therapy.[Intolerance will be considered as being 'early' if the patient chooses to cease treatment due to percieved side effect within 1 month of starting treatment, and 'late' if side-effects begin after that time]