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The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial (SOLID-TIMI 52)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000727
First Posted: October 23, 2009
Last Update Posted: August 10, 2017
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.
Collaborator:
The TIMI Study Group
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: June 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Darapladib 160 mg
Drug: Placebo
Other: Standard Therapy

  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 study was conducted at 868 centers in 36 countries: North America (282), Western Europe (210), Eastern Europe (166), Asia/Pacific (127), South America (83) during 07 December 2009 to 24 April 2014. A total of 13026 participants were randomized to the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screening phase of the study, participants presenting with acute coronary syndrome (ACS) were randomized within 30 days. Approximately 77% of participants underwent percutaneous coronary intervention (PCI) for the qualifying event.

Reporting Groups
  Description
Placebo Participants were randomized to receive matching placebo once daily.
Darapladib 160 mg Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.

Participant Flow:   Overall Study
    Placebo   Darapladib 160 mg
STARTED   6522   6504 
COMPLETED   6347   6328 
NOT COMPLETED   175   176 
Lost to Follow-up                41                43 
Withdrawal by Subject                111                109 
Study closed/terminated                23                24 



  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
Placebo Participants were randomized to receive matching placebo once daily.
Darapladib 160 mg Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
Total Total of all reporting groups

Baseline Measures
   Placebo   Darapladib 160 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 6522   6504   13026 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (9.50)   64.1  (9.52)   64.2  (9.51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1669  25.6%      1657  25.5%      3326  25.5% 
Male      4853  74.4%      4847  74.5%      9700  74.5% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White - White/Caucasian/European Heritage   5329   5331   10660 
Asian - East Asian Heritage   351   349   700 
Asian - Central/South Asian Heritage   200   211   411 
African American/African Heritage   160   155   315 
White - Arabic/North African Heritage   138   119   257 
Asian - South East Asian Heritage   123   116   239 
Asian - Japanese Heritage   109   109   218 
American Indian or Alaska Native   56   52   108 
Mixed Race   43   52   95 
Native Hawaiian or other Pacific Islander   9   5   14 
Asian - Mixed Race   2   3   5 
White - Mixed Race   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

2.  Secondary:   Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

3.  Secondary:   Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

4.  Secondary:   Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

5.  Secondary:   Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

6.  Secondary:   Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

7.  Secondary:   Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

8.  Secondary:   Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

9.  Secondary:   Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

10.  Secondary:   Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

11.  Secondary:   Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]

12.  Secondary:   Number of Participants With All-cause Mortality During the Time Period for Vital Status   [ Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ]


  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 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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01000727     History of Changes
Other Study ID Numbers: 480848/033
First Submitted: October 22, 2009
First Posted: October 23, 2009
Results First Submitted: June 9, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017