Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

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. Identifier: NCT01294462
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : May 2, 2014
Last Update Posted : June 27, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Interventions: Drug: Ticagrelor
Drug: Clopidogrel
Drug: Acetylsalicylic acid ASA

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In total, 817 patients were enrolled from 3 countries (Japan, South Korea and Taiwan). Of the randomised patients, most patients were Japanese (723 [90.3%]). The first patient was enrolled on 28 February 2010 and the last patient completed the study on 31 July 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 801 patients (401 in the ticagrelor [AZD6140 90 mg bd] group and 400 patients in the clopidogrel [clopidogrel 75 mg od] group) were randomised to treatment. The reasons for not being randomised were “Incorrect enrolment before randomisation” and “Patient decision (withdrawal of consent)”.

Reporting Groups
Ticagrelor (AZD6140) Ticagrelor (AZD6140) 90 mg bid
Clopidogrel Clopidogrel 75mg od

Participant Flow:   Overall Study
    Ticagrelor (AZD6140)   Clopidogrel
STARTED   401   400 
Received Randomized Treatment   387   380 
COMPLETED   335   337 
NOT COMPLETED   66   63 
Lost to Follow-up                1                0 
Withdrawal by Subject                65                63 

  Baseline Characteristics

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.
One discontinued patient (due to withdrawal of consent) in Ticagrelor (AZD6140) group did not agree to disclose any data. Thus the number of baseline participants in Ticagrelor (AZD6140) group is 400 instead of 401 that is the number of participants who started the first period.

Reporting Groups
Ticagrelor (AZD6140) Ticagrelor (AZD6140) 90 mg bid
Clopidogrel Clopidogrel 75mg od
Total Total of all reporting groups

Baseline Measures
   Ticagrelor (AZD6140)   Clopidogrel   Total 
Overall Participants Analyzed 
[Units: Participants]
 400   400   800 
[Units: Years]
Mean (Standard Deviation)
 67  (12)   66  (11)   67  (11) 
[Units: Participants]
Female   95   93   188 
Male   305   307   612 
Race/Ethnicity, Customized 
[Units: Participants]
Chinese   16   19   35 
Japanese   361   360   721 
Korean   23   21   44 

  Outcome Measures

1.  Primary:   Major Bleeding   [ Time Frame: Ongoing up to12 months ]

2.  Primary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: Ongoing up to 12 months ]

3.  Secondary:   Major and Minor Bleeding   [ Time Frame: Ongoing up to12 months ]

4.  Secondary:   Composite of All-cause Mortality, MI or Stroke   [ Time Frame: Ongoing up to 12 months ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

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: Judith Hsia
Organization: AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT01294462     History of Changes
Other Study ID Numbers: D5130C00027
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: July 10, 2013
Results First Posted: May 2, 2014
Last Update Posted: June 27, 2014