The effect of Colchicine on Cardiovascular Outcomes in Stroke Study (The CASPER Study)

Phase 3

Recruiting

• Conditions: Atherosclerosis; Ischemic Stroke; Transient Ischemic Attack; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Stroke - Ischaemic; Neurological - Other neurological disorders

• Registration Number: ACTRN12621001408875
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-20
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1.Presentation with an ischaemic stroke without major disability (MRS less than or equal to 3 - at time of registration [4-52 weeks]) OR clinical TIA with brain imaging evidence of acute infarction and commenced on OMT
2.hs-CRP greater than or equal to 1.0mg/L (at time of registration) 4 to 52 weeks post-stroke event
3.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments

Exclusion Criteria

1.Suspected cardio-embolic stroke/ TIA, that is probably caused by
a.Identified atrial fibrillation (permanent or paroxysmal),
b.Other identified cardiac source (intra-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction <30%),
c.Stroke/ TIA caused by dissection, endo-carditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours after carotid or cardiac surgery,
2.Hypercoagulability states,
3.Migraines related to the index stroke or TIA/ Migrainous Strokes, or inherited cerebrovascular disorders.
4.Any known intolerance to Colchicine
5.Pre-existing Colchicine treatment for greater than 7 days within the last 3 months
6.Current active myopathy with creatine kinase (CK) >3x upper limit of normal.
7.Severe liver disease or aminotransferase level >3 x upper limit of normal, within the last 3 months
8.Persistent Blood dyscrasia (white cell count or platelet count 9.Estimated glomerular filtration rate (eGFR) <30 ml/min per 1.73m2 at time of registration
10.Prior or current therapy with a strong CYP3A4 inhibitor or inducer or calcineurin inhibitor
11.Active autoimmune disease or chronic inflammatory bowel disease (defined as any disease requiring long-term or frequent immunosuppression)
12.Any other conditions that would not make it possible to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovacular Event (MACE) outcome – non-fatal stroke, Acute Coronory Sydrome (ACS) – including myocardial infarction (MI), urgent revascularisation and Cardiovacsular (CV) death.<br><br>The outcome will assess incidence using, regular follow-up and self reported events or hospitalisations, reporting of events by family members or other contacts, review of patient medical records and admission summaries and correspondence from GPs and other specialists.<br><br>[ Follow-up visits during the study treatment period are planned at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months (primary timepoint) and annually until end of study.<br>]