title: Rationale and design of the COPPS trial: a randomised, placebo-controlled, multicentre study on the use of colchicine for the primary prevention of postpericardiotomy syndrome.
abstract: BACKGROUND
  Colchicine seems to be well tolerated and effective in the treatment and prevention of pericarditis. A preliminary clinical trial has shown that colchicine may be considered not only for the treatment of postpericardiotomy syndrome (PPS), but also for its primary prevention.
  
  
  METHODS
  The COPPS study is a multicentre, double-blind, randomised trial. On the third postoperative day, 360 patients, 180 in each treatment arm, will be randomised to receive placebo or colchicine (1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients > or =70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). The primary efficacy endpoint is the incidence of PPS at 12 months. Secondary endpoints are disease-related hospitalisation, cardiac tamponade, constrictive pericarditis, and relapses at 18 months. Additional analysis will include the time to PPS.
  
  
  CONCLUSIONS
  The COPPS trial will evaluate the use of colchicine for the primary prevention of PPS. This study will also provide important information on the frequency, clinical presentation, and prognosis of this syndrome in clinical practice.
authors.affiliation: Cardiology Department, Maria Vittoria Hospital, Turin, Italy. massimo_imazio@yahoo.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Imazio
authors.forename: Enrico
authors.initials: E
authors.lastname: Cecchi
authors.forename: Brunella
authors.initials: B
authors.lastname: Demichelis
authors.forename: Alessandra
authors.initials: A
authors.lastname: Chinaglia
authors.forename: Luisella
authors.initials: L
authors.lastname: Coda
authors.forename: Aldo
authors.initials: A
authors.lastname: Ghisio
authors.forename: Daniela
authors.initials: D
authors.lastname: Demarie
authors.forename: Salvatore
authors.initials: S
authors.lastname: Ierna
authors.forename: Rita
authors.initials: R
authors.lastname: Trinchero
mesh_terms: D000328:Adult; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002317:Cardiovascular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003078:Colchicine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D015337:Multicenter Studies as Topic; D011185:Postpericardiotomy Syndrome / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D003078:Colchicine