6/28/23, 12:16 AM COPE Pathway Feedback Search Clinical Topics Home Studies COPE COPE Disease Acute pericarditis Trial question Is conventional therapy plus colchicine superior to conventional therapy alone in patients with a first episode of acute pericarditis? Study design Multi-center Open label RCT Population Characteristics of study participants 55.0% female N = 120 45.0% male 120 patients (66 female, 54 male) Inclusion criteria: patients with a first episode of acute pericarditis Key exclusion criteria: tuberculous, neoplastic, or purulent causes, severe liver disease, myopathy, blood dyscrasias or gastrointestinal disease, or pregnant and lactating women Interventions N=60 conventional therapy plus colchicine (1.0 to 2.0 mg for the first day and then a maintenance dose of 0.5 to 1.0 mg daily for 3 months plus aspirin) N=60 conventional therapy alone (aspirin 800 mg PO every 6 or 8 hours for 7 to 10 days with gradual tapering over 3 to 4 weeks) Primary outcome Recurrence at 18 months 32.3 % 32.3 https://web.pathway.md/studies/recAfrPSVmfbLfUkh 1/2 6/28/23, 12:16 AM COPE Pathway 24.2 % 16.1 % Significant decrease 10.7 8.1 % NNT = 5 0.0 % Conventional therapy plus colchicine Conventional therapy alone Significant decrease in recurrence at 18 months (10.7% vs. 32.3%; RR 0.33, 95% CI 3.1 to 10) Secondary outcomes Significant decrease in symptom persistence at 72 hours (11.7% vs. 36.7%; RR 0.32, 95% CI 0.11 to 0.53) Safety outcomes Significant difference in therapy discontinuation due to side-effects (8.3% vs. 0%). Conclusion In patients with a first episode of acute pericarditis, conventional therapy plus colchicine was superior to conventional therapy alone with respect to recurrence at 18 months. Reference Imazio M, Bobbio M, Cecchi E et al. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. Open reference URL https://web.pathway.md/studies/recAfrPSVmfbLfUkh 2/2