PeriOperative ISchemic Evaluation-2 Trial

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Hamilton Health Sciences Corporation

Washirika

McMaster University

JARIBIO LA KLINIKI: NCT01082874

BioSeek: nct01082874

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	06/30/2016
Iliyowasilishwa Kwanza:	03/07/2010
Uandikishaji uliokadiriwa Uliwasilishwa:	03/07/2010
Iliyotumwa Kwanza:	03/08/2010
Sasisho la Mwisho Liliwasilishwa:	07/13/2016
Sasisho la Mwisho Lilichapishwa:	08/24/2016
Tarehe ya matokeo ya kwanza yaliyowasilishwa:	07/13/2016
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa:	07/13/2016
Tarehe ya matokeo ya kwanza kuchapishwa:	08/24/2016
Tarehe halisi ya kuanza kwa masomo:	06/30/2010
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	02/28/2014
Tarehe ya Kukamilisha Utafiti:	12/31/2014

Hali au ugonjwa

Cardiovascular Disease

Uingiliaji / matibabu

Drug: Active Clonidine

Drug: Placebo Clonidine

Drug: Active ASA

Drug: Placebo ASA

Awamu

Awamu 3

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Active Clonidine and Active ASA
Experimental: Active Clonidine and Placebo ASA
Experimental: Placebo Clonidine and Active ASA
Placebo Comparator: Placebo Clonidine and Placebo ASA

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	45 Years Kwa 45 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	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

Matokeo

Hatua za Matokeo ya Msingi

1. Composite of All-cause Mortality and Nonfatal MI [30 days]

2. All-cause Mortality and Nonfatal MI [1 year]

Hatua za Matokeo ya Sekondari

1. Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke [30 days]

2. Individual Secondary Outcomes [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.

3. Composite Outcome by ASA Stratum [30 days]

Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.

4. Safety Outcomes in ASA Trial [30 days]

Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.

5. Safety Outcomes in Clonidine Trial [30 days]

Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.

6. Composite Outcome at 1 Year [1 year]

All-cause mortality, nonfatal MI, and nonfatal stroke.

7. Individual Secondary Outcomes at 1 Year [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.