BACKGROUND: The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. METHODS: The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing <70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality. CONCLUSIONS: The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
RCT Entities:
BACKGROUND: The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. METHODS: The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing <70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality. CONCLUSIONS: The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
Authors: A Marc Gillinov; Emilia Bagiella; Alan J Moskowitz; Jesse M Raiten; Mark A Groh; Michael E Bowdish; Gorav Ailawadi; Katherine A Kirkwood; Louis P Perrault; Michael K Parides; Robert L Smith; John A Kern; Gladys Dussault; Amy E Hackmann; Neal O Jeffries; Marissa A Miller; Wendy C Taddei-Peters; Eric A Rose; Richard D Weisel; Deborah L Williams; Ralph F Mangusan; Michael Argenziano; Ellen G Moquete; Karen L O'Sullivan; Michel Pellerin; Kinjal J Shah; James S Gammie; Mary Lou Mayer; Pierre Voisine; Annetine C Gelijns; Patrick T O'Gara; Michael J Mack Journal: N Engl J Med Date: 2016-04-04 Impact factor: 91.245
Authors: Syed Raza Shah; Richard Alweis; Syed Arbab Shah; Mohammad Hussham Arshad; Adil Al-Karim Manji; Arham Amir Arfeen; Maheen Javed; Syed Muhammad Shujauddin; Rida Irfan; Sakina Shabbir; Shehryar Shaikh Journal: J Community Hosp Intern Med Perspect Date: 2016-07-06