6/29/23, 1:41 AM POISE-2 (clonidine) Pathway Feedback Search Clinical Topics Home Studies POISE 2 (clonidine) POISE 2 (clonidine) Trial question What is the role of clonidine in patients undergoing noncardiac surgery? Study design Multi-center Double blinded RCT Population Characteristics of study participants 47.0% female N = 10010 53.0% male 10010 patients (4727 female, 5283 male) Inclusion criteria: patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery Key exclusion criteria: hypersensitivity or known allergy to clonidine, active peptic ulcer disease, intracranial hemorrhage in the 6 months before surgery, subarachnoid hemorrhage or epidural hematoma within 6 months, drug-eluting coronary stent < 1 year before surgery, or bare-metal coronary stent < 6 weeks before surgery Interventions N=5009 clonidine (0.2 mg/day just before surgery and continued until 72 hours after surgery) N=5001 placebo (matching placebo per day just before surgery and continued until 72 hours after surgery) Primary outcome Death or nonfatal myocardial infarction at 30 days 7.3 % 7.3 6.8 5.5 % 3 6 % https://web.pathway.md/studies/rec6i6FE7WW54rYT2 1/2 6/29/23, 1:41 AM 3.6 % POISE-2 (clonidine) Pathway 1.8 % No significant difference 0.0 % Clonidine Placebo No significant difference in death or nonfatal myocardial infarction at 30 days (7.3% vs. 6.8%; HR 1.08, 95% CI 0.93 to 1.26) Secondary outcomes No significant difference in death, nonfatal myocardial infarction, or nonfatal stroke (7.6% vs. 7%; HR 1.08, 95% CI 0.93 to 1.25) No significant difference in myocardial infarction (6.6% vs. 5.9%; HR 1.11, 95% CI 0.95 to 1.3) Significant increase in nonfatal cardiac arrest (0.3% vs. 0.1%; HR 3.2, 95% CI 1.17 to 8.73) Safety outcomes Significant differences in clinically important hypotension (47/6% vs. 37.1, p < 0.001) and clinically important bradycardia (12.0% vs. 8.1%, p < 0.001). Conclusion In patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery, clonidine was not superior to placebo with respect to death or nonfatal myocardial infarction at 30 days. Reference Devereaux PJ, Mrkobrada M, Sessler DI et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. Open reference URL https://web.pathway.md/studies/rec6i6FE7WW54rYT2 2/2