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A Study of Evacetrapib in High-Risk Vascular Disease (ACCELERATE)

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ClinicalTrials.gov Identifier: NCT01687998
Recruitment Status : Terminated (Study termination due to insufficient efficacy.)
First Posted : September 19, 2012
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cardiovascular Diseases
Interventions: Drug: Evacetrapib
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Non-Completers: Participants "Known to be Alive at Study End" is a subset of those who did not withdraw consent and later found to be alive from public sources. "Lost to follow-up" is a subset of those who did not withdraw consent for whom study end vital status could not be ascertained.

Reporting Groups
  Description
Evacetrapib Evacetrapib 130 milligram (mg) tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
Placebo Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.

Participant Flow:   Overall Study
    Evacetrapib   Placebo
STARTED   6038   6054 
Received at Least One Dose of Study Drug   6036   6052 
COMPLETED   5926   5934 
NOT COMPLETED   112   120 
Withdrawal by Subject                49                51 
Known to be Alive at Study End                54                62 
Lost to Follow-up                9                7 



  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
Evacetrapib Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
Placebo Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.
Total Total of all reporting groups

Baseline Measures
   Evacetrapib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6038   6054   12092 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.791  (9.3849)   64.994  (9.4591)   64.892  (9.4223) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   1390   1394   2784 
Male   4648   4660   9308 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   500   522   1022 
Not Hispanic or Latino   5394   5386   10780 
Unknown or Not Reported   144   146   290 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   243   226   469 
Asian   650   640   1290 
Native Hawaiian or Other Pacific Islander   6   5   11 
Black or African American   141   153   294 
White   4933   4971   9904 
More than one race   35   26   61 
Unknown or Not Reported   30   33   63 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Russia   85   82   167 
Hong Kong   24   28   52 
United States   2235   2240   4475 
Netherlands   171   169   340 
Austria   34   34   68 
Sweden   33   33   66 
China   224   221   445 
South Korea   87   94   181 
Poland   243   240   483 
Brazil   54   56   110 
Slovakia   116   117   233 
France   45   52   97 
Bulgaria   113   118   231 
Lithuania   13   15   28 
Argentina   89   91   180 
Romania   64   66   130 
Hungary   118   115   233 
Japan   205   202   407 
Ukraine   67   66   133 
United Kingdom   58   58   116 
Switzerland   15   14   29 
Spain   65   66   131 
New Zealand   63   64   127 
Canada   626   619   1245 
Czechia   187   185   372 
Turkey   1   2   3 
Belgium   42   42   84 
Taiwan   52   53   105 
Denmark   95   100   195 
Italy   43   40   83 
Mexico   235   231   466 
South Africa   77   76   153 
Israel   72   74   146 
Australia   159   160   319 
Germany   198   202   400 
Estonia   30   29   59 


  Outcome Measures

1.  Primary:   Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)   [ Time Frame: Baseline to Study Completion (Up to 4 years) ]

2.  Secondary:   Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels   [ Time Frame: Baseline, 3 Months ]

3.  Secondary:   Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA   [ Time Frame: Baseline through End of Study (Up to 4 years) ]

4.  Secondary:   Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization   [ Time Frame: Baseline through End of Study (Up to 4 years) ]

5.  Secondary:   Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA   [ Time Frame: Baseline through End of Study (Up to 4 years) ]

6.  Secondary:   Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke   [ Time Frame: Baseline through End of Study (Up to 4 years) ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979
e-mail: ClinicalTrials.gov@lilly.com


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01687998     History of Changes
Other Study ID Numbers: 11949
I1V-MC-EIAN ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2012
First Posted: September 19, 2012
Results First Submitted: February 18, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018