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

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

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.
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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%

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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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