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

Health Conditions
  • Cardiovascular Disease
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Garg AX, Kurz A, Sessler DI, Cuerden M, Robinson A, Mrkobrada M, Parikh C, Mizera R, Jones PM, Tiboni M, Rodriguez RG, Popova E, Rojas Gomez MF, Meyhoff CS, Vanhelder T, Chan MT, Torres D, Parlow J, de Nadal Clanchet M, Amir M, Bidgoli SJ, Pasin L, Martinsen K, Malaga G, Myles P, Acedillo R, Roshanov P, Walsh M, Dresser G, Kumar P, Fleischmann E, Villar JC, Painter T, Biccard B, Bergese S, Srinathan S, Cata JP, Chan V, Mehra B, Leslie K, Whitlock R, Devereaux PJ; POISE-2 Investigators. Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial. BMJ Open. 2014 Feb 25;4(2):e004886. doi: 10.1136/bmjopen-2014-004886.; 24568963
Countries of Recruitment
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
Participant Sex
Both
Participant Age Range
45 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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
Interventions
Drug; Active Clonidine; Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.; [Active Clonidine and Active ASA, Active Clonidine and Placebo ASA]; Drug; Placebo Clonidine; Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.; [Placebo Clonidine and Active ASA, Placebo Clonidine and Placebo ASA]; Drug; Active ASA; Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery; [Active Clonidine and Active ASA, Placebo Clonidine and Active ASA]; Drug; Placebo ASA; Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery; [Active Clonidine and Placebo ASA, Placebo Clonidine and Placebo ASA]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Results Reporting
Sorry, this information is not available
Acronym
POISE-2
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
Secondary Trial Identifying Number
2009-018173-31
Website
Sorry, this information is not available
Study Funded By
Hamilton Health Sciences Corporation
Funder Type
Sorry, this information is not available
Study Sponsored By
Hamilton Health Sciences Corporation
Study Also Sponsored By
McMaster University
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

08 Mar 2010

Last Updated

07 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015