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The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY)

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ClinicalTrials.gov Identifier: NCT00799903
Recruitment Status : Completed
First Posted : December 1, 2008
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atherosclerosis
Interventions: Drug: Darapladib
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study consisted of a Screening Phase of up to 8 weeks duration, a Treatment Phase, an End-of-Treatment (EOT) visit, and a Follow-up visit scheduled for 35 +/- 7 days after last study drug intake. The median treatment duration was anticipated to be 2.75 years.

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 chronic Coronary Heart Disease (CHD) were randomized within 8 weeks. In addition to chronic CHD, participants were required to have at least one additional predictor of cardiovascular risk specified in the protocol.

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

Participant Flow:   Overall Study
    Placebo   Darapladib
STARTED   7904   7924 
COMPLETED   7631   7646 
NOT COMPLETED   273   278 
Investigator Site Closed                25                23 
Withdrawal by Subject                179                175 
Lost to Follow-up                69                80 



  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.
No text entered.

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

Baseline Measures
   Placebo   Darapladib   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 7904   7924   15828 
Age 
[Units: Years]
Mean (Standard Deviation) 		 64.3  (9.39)   64.5  (9.31)   64.4  (9.35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      1506  19.1%      1461  18.4%      2967  18.7% 
Male      6398  80.9%      6463  81.6%      12861  81.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
American Indian or Alaska Native      108   1.4%      106   1.3%      214   1.4% 
Asian      1366  17.3%      1351  17.0%      2717  17.2% 
Native Hawaiian or Other Pacific Islander      11   0.1%      4   0.1%      15   0.1% 
Black or African American      191   2.4%      175   2.2%      366   2.3% 
White      6177  78.2%      6233  78.7%      12410  78.4% 
More than one race      51   0.6%      55   0.7%      106   0.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 2

3.  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 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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With CV Death 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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With First Occurrence of MI (Fatal/Non-fatal) 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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) 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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, 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 4.25 years/average of 3.51 years) ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With All-cause Mortality During the Time Period for Vital Status   [ Time Frame: From randomization until death or study completion (up to 4.49 years/average of 3.65 years) ]
  Show Outcome Measure 8


  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
No text entered.


  More Information

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):
STABILITY Investigators, White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, López-Sendón J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00799903     History of Changes
Other Study ID Numbers: 100601
First Submitted: November 26, 2008
First Posted: December 1, 2008
Results First Submitted: July 12, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017