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PeriOperative ISchemic Evaluation-2 Trial (POISE-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01082874
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 9, 2010
Results First Submitted Date  ICMJE July 14, 2016
Results First Posted Date  ICMJE August 25, 2016
Last Update Posted Date August 25, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • Composite of All-cause Mortality and Nonfatal MI [ Time Frame: 30 days ]
  • All-cause Mortality and Nonfatal MI [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
Composite of All-cause Mortality and Nonfatal MI [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
  • Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke [ Time Frame: 30 days ]
  • Individual Secondary Outcomes [ Time Frame: 30 days ]
    All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.
  • Composite Outcome by ASA Stratum [ Time Frame: 30 days ]
    Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.
  • Safety Outcomes in ASA Trial [ Time Frame: 30 days ]
    Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.
  • Safety Outcomes in Clonidine Trial [ Time Frame: 30 days ]
    Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.
  • Composite Outcome at 1 Year [ Time Frame: 1 year ]
    All-cause mortality, nonfatal MI, and nonfatal stroke.
  • Individual Secondary Outcomes at 1 Year [ Time Frame: 1 year ]
    All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
Stroke, congestive heart failure, life-threatening bleeding, and major bleeding, clinically important hypotension, clinically important bradycardia [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PeriOperative ISchemic Evaluation-2 Trial
Official Title  ICMJE 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
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • 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.
    Other Name: CATAPRES, CATAPRES-TTS
  • 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.
  • 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
    Other Name: ASPIRIN
  • 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
Study Arms  ICMJE
  • Experimental: Active Clonidine and Active ASA
    Interventions:
    • Drug: Active Clonidine
    • Drug: Active ASA
  • Experimental: Active Clonidine and Placebo ASA
    Interventions:
    • Drug: Active Clonidine
    • Drug: Placebo ASA
  • Experimental: Placebo Clonidine and Active ASA
    Interventions:
    • Drug: Placebo Clonidine
    • Drug: Active ASA
  • Placebo Comparator: Placebo Clonidine and Placebo ASA
    Interventions:
    • Drug: Placebo Clonidine
    • Drug: Placebo ASA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2014)
10010
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2010)
10000
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries China,   Egypt,   El Salvador,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT01082874
Other Study ID Numbers  ICMJE POISE-2 01MAR2010
2009-018173-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University ( Hamilton Health Sciences Corporation )
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE McMaster University
Investigators  ICMJE
Principal Investigator: P.J. Devereaux, MD, PhD Population Health Research Institute
Study Chair: Salim Yusuf, DPhil Population Health Research Institute
PRS Account McMaster University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP