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Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin (PEGASUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01225562
First received: July 9, 2010
Last updated: December 18, 2015
Last verified: December 2015
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Myocardial Infarction
Cardiovascular Death
Atherothrombosis
Stroke
Interventions: Drug: Ticagrelor 90 mg
Drug: Ticagrelor 60 mg
Drug: Ticagrelor Placebo

  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
The Participant Flow shows patients randomized. This number is different from patients enrolled in the protocol section which includes patients who were enrolled, but not randomized.

Reporting Groups
  Description
Ticagrelor 90 mg Ticagrelor 90 mg twice daily (BD)
Ticagrelor 60 mg Ticagrelor 60 mg twice daily (BD)
Placebo Matching placebo

Participant Flow:   Overall Study
    Ticagrelor 90 mg   Ticagrelor 60 mg   Placebo
STARTED   7050   7045   7067 
COMPLETED   6995   6989   7014 
NOT COMPLETED   55   56   53 
Withdrawal by Subject                52                50                52 
Lost to Follow-up                3                6                1 



  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
Ticagrelor 90 mg Ticagrelor 90 mg twice daily (BD)
Ticagrelor 60 mg Ticagrelor 60 mg twice daily (BD)
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
   Ticagrelor 90 mg   Ticagrelor 60 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7050   7045   7067   21162 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.4  (8.4)   65.2  (8.4)   65.4  (8.3)   65.3  (8.3) 
Gender 
[Units: Participants]
       
Female   1682   1661   1717   5060 
Male   5368   5384   5350   16102 


  Outcome Measures
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1.  Primary:   Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization   [ Time Frame: Randomization up to 47 months ]

2.  Primary:   Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients   [ Time Frame: First dosing up to 48 months ]

3.  Secondary:   Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization   [ Time Frame: Randomization up to 47 months ]

4.  Secondary:   Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization   [ Time Frame: Randomization up to 47 months ]


  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
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  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: Anders Himmelmann, MD PhD
Organization: AstraZeneca AB
phone: +46 31 7761000
e-mail: ClinicalTrialTransparency@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01225562     History of Changes
Other Study ID Numbers: D5132C00001
2009-017242-30 ( EudraCT Number )
Study First Received: July 9, 2010
Results First Received: November 4, 2015
Last Updated: December 18, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Peru: Instituto Nacional de Salud
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Turkey: Ministry of Health
Ukraine: Ministry of Health
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency