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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Cardiovascular Disease
Interventions Drug: Active Clonidine
Drug: Placebo Clonidine
Drug: Active ASA
Drug: Placebo ASA
Enrollment 10010
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA
Hide Arm/Group Description

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 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: 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.

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

Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.

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

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 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

Period Title: Overall Study
Started 2499 2510 2499 2502
Completed 2488 2498 2488 2489
Not Completed 11 12 11 13
Reason Not Completed
Lost to Follow-up             10             10             6             10
Withdrawal by Subject             1             2             5             3
Arm/Group Title Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA Total
Hide Arm/Group Description

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 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: 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.

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

Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.

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

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 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

Total of all reporting groups
Overall Number of Baseline Participants 2499 2510 2499 2502 10010
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2499 participants 2510 participants 2499 participants 2502 participants 10010 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
873
  34.9%
836
  33.3%
836
  33.5%
866
  34.6%
3411
  34.1%
>=65 years
1626
  65.1%
1674
  66.7%
1663
  66.5%
1636
  65.4%
6599
  65.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2499 participants 2510 participants 2499 participants 2502 participants 10010 participants
68.4  (10.4) 68.6  (10.3) 68.7  (10.2) 68.5  (10.3) 68.6  (10.3)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2499 participants 2510 participants 2499 participants 2502 participants 10010 participants
Female 1212 1164 1188 1160 4724
Male 1287 1346 1310 1340 5283
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2499 participants 2510 participants 2499 participants 2502 participants 10010 participants
Colombia 162 161 164 162 649
Argentina 3 2 3 3 11
Hong Kong 69 70 69 68 276
United States 443 440 437 440 1760
United Kingdom 22 22 22 20 86
Malaysia 30 28 30 32 120
Switzerland 24 24 25 23 96
India 149 149 151 146 595
Spain 133 139 131 135 538
New Zealand 14 11 11 10 46
Canada 875 878 872 873 3498
Austria 44 44 42 46 176
Pakistan 43 44 44 44 175
Belgium 44 47 46 47 184
Brazil 13 12 16 16 57
Denmark 80 80 80 81 321
Italy 39 39 38 38 154
South Africa 87 87 89 90 353
Australia 119 120 113 118 470
Chile 38 38 38 39 153
France 21 24 24 20 89
Peru 41 44 43 44 172
Germany 6 7 11 7 31
1.Primary Outcome
Title Composite of All-cause Mortality and Nonfatal MI
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA
Hide Arm/Group Description:

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 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: 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.

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

Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.

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

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 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

Overall Number of Participants Analyzed 2499 2510 2499 2502
Measure Type: Number
Unit of Measure: participants
173 194 178 161
2.Primary Outcome
Title All-cause Mortality and Nonfatal MI
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke
Hide Description [Not Specified]
Time Frame 30 days
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Individual Secondary Outcomes
Hide Description 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.
Time Frame 30 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Composite Outcome by ASA Stratum
Hide Description Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.
Time Frame 30 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Safety Outcomes in ASA Trial
Hide Description Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.
Time Frame 30 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Safety Outcomes in Clonidine Trial
Hide Description Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.
Time Frame 30 days
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Composite Outcome at 1 Year
Hide Description All-cause mortality, nonfatal MI, and nonfatal stroke.
Time Frame 1 year
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Individual Secondary Outcomes at 1 Year
Hide Description 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.
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA
Hide Arm/Group Description

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 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: 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.

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

Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.

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

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 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

All-Cause Mortality
Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/2499 (1.84%)      52/2510 (2.07%)      45/2499 (1.80%)      39/2502 (1.56%)    
Blood and lymphatic system disorders         
Anemia  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Dissemianted intravascular coagulation  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Cardiac disorders         
atrial fibrillation  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Atrial Flutter  0/2499 (0.00%)  0 0/2510 (0.00%)  0 2/2499 (0.08%)  2 0/2502 (0.00%)  0
Myocardial Infarction  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Sinus Arrest  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Supraventricular Tachycardia  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Tachy Arrythymia  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Eye disorders         
Open Angle Glaucoma  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Gastrointestinal disorders         
Abdominal Distension  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Colitis  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Duodenal Ulcer  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Enterocutaneous Fistula  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Enterovesicle Fistula  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
GI Hemmorhage  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Hernial Eventration  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Ileus  0/2499 (0.00%)  0 3/2510 (0.12%)  3 0/2499 (0.00%)  0 0/2502 (0.00%) 
Ileus paralytic  0/2499 (0.00%)  0 1/2510 (0.04%)  1 2/2499 (0.08%)  2 0/2502 (0.00%)  0
Intestinal Dilatation  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Intestinal Fistuala  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Intestinal Ischemia  2/2499 (0.08%)  2 1/2510 (0.04%)  1 2/2499 (0.08%)  2 0/2502 (0.00%)  0
Intestinal Obstruction  1/2499 (0.04%)  1 0/2510 (0.00%)  0 2/2499 (0.08%)  2 0/2502 (0.00%)  0
Intestinal Perforation  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Large Intestine Perforation  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Mesenteric Vein Thrombosis  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Pneumoretroperitonium  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Rectum hemorrhage  2/2499 (0.08%)  2 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Samll Intestinal Obstruction  1/2499 (0.04%)  1 3/2510 (0.12%)  3 1/2499 (0.04%)  1 1/2502 (0.04%)  1
Volvulus  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Vomiting  0/2499 (0.00%)  0 1/2510 (0.04%)  1 2/2499 (0.08%)  2 1/2502 (0.04%)  1
General disorders         
Device Dislocation  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 1/2502 (0.04%)  1
Gait disturbance  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Impaired Healing  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Multi-organ Failure  2/2499 (0.08%)  2 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Pain  0/2499 (0.00%)  0 1/2510 (0.04%)  1 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Pyrexia  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis Acute  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Cirrhosis Alcoholic  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Ischemic Hepatitis  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Portal Vein Thrombosis  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Immune system disorders         
Drug Hypersensitivity  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hypersensitivity  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Infections and infestations         
Appendicitis  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Cellulitis  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Injury, poisoning and procedural complications         
Abdominal Wound Dehisence  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Anastomotic Leak  1/2499 (0.04%)  1 3/2510 (0.12%)  3 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Ankle Fracture  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Bladder Injury  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Endotrachial Intubation complication  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Fall  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Fascial Rupture  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Femur Fracture  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Gastrointestinal Anastomotic Leak  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Gastrointestinal Stoma Necrosis  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Humerous Fracture  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Incision Site Hemorrhage  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Incisional Hernia  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Joint Dislocation  0/2499 (0.00%)  0 1/2510 (0.04%)  1 2/2499 (0.08%)  2 1/2502 (0.04%)  1
Lymphatic Duct Injury  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Overdose  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Pancreatic leak  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Postoperative Ileus  2/2499 (0.08%)  2 0/2510 (0.00%)  0 3/2499 (0.12%)  3 0/2502 (0.00%)  0
Postoperative Thoracic Procedure Complication  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Subcutaneous Hematoma  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Subdural Hemorrhage  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Wound Evisceration  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 2/2502 (0.08%)  2
Wound Hematoma  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Investigations         
Blood Pressure Systolic Increase  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hemoglobin decrease  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Internatinal Normalized Ratio Increased  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Liver Functin Test Abnormal  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Thoracic Cavity Drainage test Abnormal  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Metabolism and nutrition disorders         
Dehydration  2/2499 (0.08%)  2 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Electrolyte Imbalance  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Hypercalcemia  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hyperglycemia  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hyponatremia  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Musculoskeletal and connective tissue disorders         
Muscular Weakness  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
b-Cell Lymphoma  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Myeloproliferative disorder  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Neuroendocrine Carcinoma Metatastic  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Transitional Cell Carcinoma  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Nervous system disorders         
Cognitive Disorder  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Loss of Consciousness  1/2499 (0.04%)  1 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Peroneal Nerve Palsy  1/2499 (0.04%)  1 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Pre-syncope  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Syncope  1/2499 (0.04%)  1 1/2510 (0.04%)  1 2/2499 (0.08%)  2 0/2502 (0.00%)  0
TIA  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%) 
Vasculitis Cerebral  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Vocal Cord Paralysis  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Psychiatric disorders         
Confusinal State  0/2499 (0.00%)  0 2/2510 (0.08%)  2 0/2499 (0.00%)  0 3/2502 (0.12%)  3
Dilirium  1/2499 (0.04%)  1 3/2510 (0.12%)  3 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Emotional Distress  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Mental Disorder  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Renal and urinary disorders         
Acute Pre-renal Failure  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hematuria  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Pelvic-UretericObstruction  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Renal Cyst Rupture  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Renal Failure  1/2499 (0.04%)  1 2/2510 (0.08%)  2 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Renal Failure Acute  1/2499 (0.04%)  1 0/2510 (0.00%)  0 2/2499 (0.08%)  2 4/2502 (0.16%)  4
Renal Ischemia  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Urinary retention  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Actue Respiratory Distress syndrome  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Acute Respiratory Failure  2/2499 (0.08%)  2 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Broncho Spasm  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Chylothorax  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
Dyspnea  0/2499 (0.00%)  0 1/2510 (0.04%)  1 2/2499 (0.08%)  2 2/2502 (0.08%)  2
Hypoxia  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
pleural Effusion  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Pneumonia Aspiration  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Pneumothorax  0/2499 (0.00%)  0 0/2510 (0.00%)  0 2/2499 (0.08%)  2 1/2502 (0.04%)  1
Pulmonary Edema  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Respiratory Arrest  0/2499 (0.00%)  0 1/2510 (0.04%)  1 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Respiratory Depression  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Respiratory Distress  2/2499 (0.08%)  2 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Respiratory Failure  1/2499 (0.04%)  1 2/2510 (0.08%)  2 4/2499 (0.16%)  4 2/2502 (0.08%)  2
Skin and subcutaneous tissue disorders         
Decubitus Ulcer  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Dermatitis Allergic  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Rash  2/2499 (0.08%)  2 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Subcutaneous Emphysema  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Vascular disorders         
Hematoma  0/2499 (0.00%)  0 0/2510 (0.00%)  0 1/2499 (0.04%)  1 0/2502 (0.00%)  0
Hypotension  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Lymphocele  0/2499 (0.00%)  0 0/2510 (0.00%)  0 0/2499 (0.00%)  0 1/2502 (0.04%)  1
lymphorrhoea  0/2499 (0.00%)  0 1/2510 (0.04%)  1 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Orthostatic Hypotension  1/2499 (0.04%)  1 0/2510 (0.00%)  0 0/2499 (0.00%)  0 0/2502 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Clonidine and Active ASA Active Clonidine and Placebo ASA Placebo Clonidine and Active ASA Placebo Clonidine and Placebo ASA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2499 (0.00%)      0/2510 (0.00%)      0/2499 (0.00%)      0/2502 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: P.J. Devereaux, MD, PhD, FRCPC
Organization: Population Health Research Institute
Phone: 905-527-4322 ext 40654
EMail: philipj@mcmaster.ca
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT01082874    
Other Study ID Numbers: POISE-2 01MAR2010
2009-018173-31 ( EudraCT Number )
First Submitted: March 8, 2010
First Posted: March 9, 2010
Results First Submitted: July 14, 2016
Results First Posted: August 25, 2016
Last Update Posted: August 25, 2016