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Trial record 2 of 6 for:    CARDIOVASCULAR POISE

PeriOperative ISchemic Evaluation-2 Trial (POISE-2)

This study has been completed.
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: July 14, 2016
Last verified: July 2016
Results First Received: July 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cardiovascular Disease
Interventions: Drug: Active Clonidine
Drug: Placebo Clonidine
Drug: Active ASA
Drug: Placebo ASA

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Clonidine and Active ASA

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 and Placebo ASA

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 and Active ASA

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 and Placebo ASA

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


Participant Flow:   Overall Study
    Active Clonidine and Active ASA   Active Clonidine and Placebo ASA   Placebo Clonidine and Active ASA   Placebo Clonidine and Placebo ASA
STARTED   2499   2510   2499   2502 
COMPLETED   2488   2498   2488   2489 
NOT COMPLETED   11   12   11   13 
Lost to Follow-up                10                10                6                10 
Withdrawal by Subject                1                2                5                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Clonidine and Active ASA

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 and Placebo ASA

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 and Active ASA

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 and Placebo ASA

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 Total of all reporting groups

Baseline Measures
   Active Clonidine and Active ASA   Active Clonidine and Placebo ASA   Placebo Clonidine and Active ASA   Placebo Clonidine and Placebo ASA   Total 
Overall Participants Analyzed 
[Units: Participants]
 2499   2510   2499   2502   10010 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   873   836   836   866   3411 
>=65 years   1626   1674   1663   1636   6599 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.4  (10.4)   68.6  (10.3)   68.7  (10.2)   68.5  (10.3)   68.6  (10.3) 
Gender 
[Units: Participants]
         
Female   1212   1164   1188   1160   4724 
Male   1287   1346   1310   1340   5283 
Region of Enrollment 
[Units: 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 


  Outcome Measures

1.  Primary:   Composite of All-cause Mortality and Nonfatal MI   [ Time Frame: 30 days ]

2.  Primary:   All-cause Mortality and Nonfatal MI   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Individual Secondary Outcomes   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Composite Outcome by ASA Stratum   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Safety Outcomes in ASA Trial   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Safety Outcomes in Clonidine Trial   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Composite Outcome at 1 Year   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Individual Secondary Outcomes at 1 Year   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: P.J. Devereaux, MD, PhD, FRCPC
Organization: Population Health Research Institute
phone: 905-527-4322 ext 40654
e-mail: philipj@mcmaster.ca


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT01082874     History of Changes
Other Study ID Numbers: POISE-2 01MAR2010
2009-018173-31 ( EudraCT Number )
Study First Received: March 8, 2010
Results First Received: July 14, 2016
Last Updated: July 14, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
India: Ministry of Health
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
New Zealand: Medsafe
Pakistan: Ministry of Health
Peru: Instituto Nacional de Salud
South Africa: Medicines Control Council
Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration