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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  
Number of Participants  
[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