Trial record 2 of 4 for:    CARDIOVASCULAR POISE

PeriOperative ISchemic Evaluation-2 Trial (POISE-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT01082874
First received: March 8, 2010
Last updated: April 20, 2014
Last verified: April 2014

March 8, 2010
April 20, 2014
July 2010
March 2014   (final data collection date for primary outcome measure)
  • Composite of all-cause mortality and nonfatal MI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All-cause mortality and nonfatal MI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01082874 on ClinicalTrials.gov Archive Site
  • Composite of all-cause mortality, nonfatal MI, and nonfatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Individual secondary outcomes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.
  • Safety outcomes in clonidine trial [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.
  • Composite outcome at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All-cause mortality, nonfatal MI, and nonfatal stroke.
  • Individual secondary outcomes at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.
Stroke, congestive heart failure, life-threatening bleeding, and major bleeding, clinically important hypotension, clinically important bradycardia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
PeriOperative ISchemic Evaluation-2 Trial
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Disease
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10010
January 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT01082874
POISE-2 01MAR2010, 2009-018173-31
Yes
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: P.J. Devereaux, MD, PhD Population Health Research Institute
Study Chair: Salim Yusuf, DPhil Population Health Research Institute
McMaster University
April 2014

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