We recently showed that oral colchicine has striking anti-inflammatory and plaque-stabilising properties in ACS patients already on optimal medical therapy (OMT), including high dose statin. In particular, we found that in ACS patients, "single shot" colchicine markedly suppresses monocyte inflammasome activation and trans-coronary inflammatory cytokine levels (PMID: 26304941). Also, long-term oral colchicine therapy in patients post-ACS resulted in coronary plaque stabilisation and a concomitant reduction in plasma CRP concentrations (PMID: 29055633).
Here we will perform a randomised control trial, examining the effects of long-term, low-dose, colchicine (0.5 mg/day) plus OMT, versus placebo plus OMT, on key vascular and clinical endpoints.
Patients post-ACS, who have elevated biochemical markers suggestive of persistent coronary inflammation (hsCRP ≥3 mg/L) measured 4 weeks after the ACS, and with the highest risk of recurrent MACE, will be selected as they are expected to derive most benefit from suppression of coronary inflammation.
Vascular endpoints include:
- coronary inflammation imaging, to identify ruptured and high-risk atherosclerotic plaques in patients with coronary disease;
- arterial endothelial dysfunction, assessed by flow mediated dilatation, which is driven by vascular inflammation, and strongly correlates with future cardiovascular events; and
- carotid atheroma stability, which also correlates strongly with overall cardiovascular risk; its superficial location lends itself to imaging and histologic assessment.