COPE
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
45.0% male
N = 120
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
10.7%
32.3%
32.3 %
24.2 %
16.1 %
8.1 %
0.0 %
Conventional therapy plus
colchicine
Conventional therapy
alone
Significant
decrease ▼
NNT = 4
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.
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