A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome (PLATO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00391872
First received: October 23, 2006
Last updated: February 10, 2012
Last verified: February 2012
Results First Received: January 31, 2011  
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: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Ticagrelor
Drug: Clopidogrel

  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
The first participant was enrolled on 11 October 2006 and the last participant completed the study on 27 February 2009. Study participants were randomized from 855 centers in 43 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants will already be hospitalized due to their acute condition, and must be enrolled and randomized within 24 hours of the onset of their most recent cardiac ischemic symptoms. Randomization should take place as soon as possible after presentation.

Reporting Groups
  Description
TICAGRELOR Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL Clopidogrel 75 mg once daily dose (ODD)

Participant Flow:   Overall Study
    TICAGRELOR     CLOPIDOGREL  
STARTED     9333     9291  
COMPLETED     9026     9036  
NOT COMPLETED     307     255  
Protocol Violation                 7                 2  
Withdrawal by Subject                 296                 249  
Reason unknown                 2                 4  
Lost to Follow-up                 2                 0  



  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 Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL Clopidogrel 75 mg once daily dose (ODD)
Total Total of all reporting groups

Baseline Measures
    TICAGRELOR     CLOPIDOGREL     Total  
Number of Participants  
[units: participants]
  9333     9291     18624  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 11.21     62.3  ± 11.21     62.2  ± 22.42  
Gender  
[units: Participants]
     
Female     2655     2633     5288  
Male     6678     6658     13336  



  Outcome Measures
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1.  Primary:   Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke   [ Time Frame: Randomization up to 12 months ]

2.  Primary:   Participants With Any Major Bleeding Event   [ Time Frame: First dosing up to 12 months ]

3.  Secondary:   Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization   [ Time Frame: Randomization up to 12 months ]

4.  Secondary:   Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke   [ Time Frame: Randomization up to 12 months ]

5.  Secondary:   Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.   [ Time Frame: Randomization up to 12 months ]

6.  Secondary:   Participants With MI Event   [ Time Frame: Randomization up to 12 months ]

7.  Secondary:   Participants With Death From Vascular Causes   [ Time Frame: Randomization up to 12 months ]

8.  Secondary:   Participants With Stroke   [ Time Frame: Randomization up to 12 months ]

9.  Secondary:   Participants With Death From Any Cause   [ Time Frame: Randomization up to 12 months ]

10.  Secondary:   Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding   [ Time Frame: First dosing up to 12 months ]

11.  Secondary:   Participants With Major or Minor Bleeding   [ Time Frame: First dosing up to 12 months ]

12.  Secondary:   Participants With Non-procedural Major Bleeding   [ Time Frame: First dosing up to 12 months ]

13.  Secondary:   Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding   [ Time Frame: First dosing up to 12 months   ]

14.  Secondary:   Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding   [ Time Frame: First dosing up to 12 months ]

15.  Secondary:   Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization   [ Time Frame: 1-week period following randomization ]

16.  Secondary:   Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization   [ Time Frame: 1-week period following randomization ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00391872     History of Changes
Other Study ID Numbers: D5130C05262, PLATO
Study First Received: October 23, 2006
Results First Received: January 31, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration