PeriOperative ISchemic Evaluation-2 Trial | Completed
PeriOperative ISchemic Evaluation-2 Trial
POISE-2
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Cardiovascular Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01082874
Primary Trial ID Number
Summary
Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.
Research Details
  • POISE-2 is a multicentre, international, blinded, 2x2 factorial randomized controlled trial of acetyl-salicylic acid (ASA) and clonidine. The primary objective is to determine the impact of clonidine versus placebo and ASA versus placebo on the 30-day risk of all-cause mortality or nonfatal myocardial infarction in patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Patients in the POISE-2 trial will be randomly assigned to one of four groups: ASA and Clonidine together, ASA and Clonidine placebo, ASA placebo and Clonidine, or a ASA placebo and Clonidine placebo. Research personnel will follow patients at 30 days post-randomization and 1 year post-randomization.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Study Type
Interventional
Intervention
Drug : Active Clonidine, Drug : Placebo Clonidine, Drug : Active ASA, Drug : Placebo ASA

Study Arm Groups : Active Clonidine and Active ASA, Active Clonidine and Placebo ASA, Placebo Clonidine and Active ASA, Placebo Clonidine and Placebo ASA, Active Clonidine and Active ASA, Placebo Clonidine and Active ASA, Active Clonidine and Placebo ASA, Placebo Clonidine and Placebo ASA

Intervention Type
See Interventions above
Primary Outcome Measures
  • Composite of all-cause mortality and nonfatal MI; 30 days; All-cause mortality and nonfatal MI; 1 year
Secondary Outcome Measures
  • Composite of all-cause mortality, nonfatal MI, and nonfatal stroke; 30 days; Individual secondary outcomes; 30 days; Composite outcome by ASA stratum; 30 days; Safety outcomes in ASA trial; 30 days; Safety outcomes in clonidine trial; 30 days; Composite outcome at 1 year; 1 year; Individual secondary outcomes at 1 year; 1 year
Publication(s)
Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.; 24679062; Devereaux PJ, Sessler DI, Leslie K, Kurz A, Mrkobrada M, Alonso-Coello P, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, Vanhelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Clonidine in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1504-13. doi: 10.1056/NEJMoa1401106. Epub 2014 Mar 31.; 24679061
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
45 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • 1. Are undergoing noncardiac surgery;
  • 2. Are ≥ 45 years of age;
  • 3. Are expected to require at least an overnight hospital admission after surgery; AND
  • 4. Fulfill one or more of the following 5 criteria:
  • - History of coronary artery disease
  • - History of peripheral vascular disease
  • - History of stroke
  • - Undergoing major vascular surgery
  • - Any 3 of the following 9 criteria:
  • - undergoing major surgery (i.e. intraperitoneal, intrathoracic,
  • retroperitoneal or major orthopedic surgery
  • - history of congestive heart failure
  • - transient ischemic attack
  • - diabetes and currently taking an oral hypoglycemic agent or insulin
  • - age ≥ 70 years
  • - hypertension
  • - serum creatinine > 175 µmol/L (> 2.0 mg/dL)
  • - history of smoking within 2 years of surgery
  • - undergoing urgent/emergent surgery
  • Exclusion Criteria:
  • 1. Consumption of ASA within 72 hours prior to surgery
  • 2. Hypersensitivity or known allergy to ASA or clonidine
  • 3. Systolic blood pressure < 105 mm Hg
  • 4. Heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker
  • 5. Second or third degree heart block without a permanent pacemaker
  • 6. Active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks
  • 7. Intracranial hemorrhage documented by neuro-imaging, in the 6 months prior to
  • randomization. This does not include petechial hemorrhagic transformation of a
  • primary ischemic stroke
  • 8. Subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6
  • months prior to randomization and the offending aneurysm or arterial lesion has been
  • repaired
  • 9. Drug-eluting coronary stent in the year prior to randomization
  • 10. Bare-metal coronary stent in the 6 weeks prior to randomization
  • 11. Thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel) or ticagrelor within 72
  • hours prior to surgery; or intent to restart a thienopyridine or ticagrelor during
  • the first 7 days post-op; or currently taking an alpha-2 agonist, alpha methyldopa,
  • monoamine oxidase inhibitors or reserpine;
  • 12. Planned use - during the first 3 days after surgery - therapeutic dose
  • anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent
  • 13. Undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
  • 14. Not consenting to participate in POISE-2 prior to surgery
  • 15. Previously enrolled in POISE-2 Trial
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Investigational Site 7006
Hull
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Hong Kong, India, Italy, Malaysia, New Zealand, Pakistan, Peru, South Africa, Spain, Switzerland, United Kingdom
Scientific Title
A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event
EudraCT Number
Not available for this trial
Funder(s)
  • McMaster University
Other Study ID Numbers
POISE-2 01MAR2010
Sponsor(s)
Hamilton Health Sciences Corporation
Key Dates

Recruitment Start Date

Jul 2010

Recruitment End Date

Mar 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

08 Mar 2010

Last Updated

07 Apr 2015