A Phase 3 interventional study of Evacetrapib and Placebo in Cardiovascular Diseases, sponsored by Eli Lilly and Company. Terminated at 444 sites in 37 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 12,092 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meet 1 of the following criteria:
Exclusion Criteria:
Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
Drug: Evacetrapib
Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.
Drug: Placebo
Administered Orally
Also known as: LY2484595
Administered Orally
Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Time frame: Baseline to Study Completion (Up to 4 years)
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
Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Time frame: Baseline through End of Study (Up to 4 years)
Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Time frame: Baseline through End of Study (Up to 4 years)
Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Time frame: Baseline through End of Study (Up to 4 years)
Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Time frame: Baseline through End of Study (Up to 4 years)
| Milestone | Evacetrapib | Placebo |
|---|---|---|
| Started | 6038 | 6054 |
| Received at least one dose of study drug | 6036 | 6052 |
| Completed | 5926 | 5934 |
| Not completed | 112 | 120 |
| Withdrew: Withdrawal by subject | 49 | 51 |
| Withdrew: Known to be alive at study end | 54 | 62 |
| Withdrew: Lost to follow-up | 9 | 7 |
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
| Participants | Evacetrapib | Placebo |
|---|---|---|
| Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) | 779 | 776 |
| percent | Evacetrapib | Placebo |
|---|---|---|
| LDL-C | -31.12 ± 27.583 | 5.99 ± 29.007 |
| HDL-C | 133.18 ± 57.204 | 1.63 ± 17.455 |
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
| Participants | Evacetrapib | Placebo |
|---|---|---|
| Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA | 857 | 867 |
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
| Participants | Evacetrapib | Placebo |
|---|---|---|
| Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization | 690 | 691 |
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
| Participants | Evacetrapib | Placebo |
|---|---|---|
| Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA | 571 | 570 |
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
| Participants | Evacetrapib | Placebo |
|---|---|---|
| Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke | 437 | 453 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evacetrapib | — | 2,306/6,036 (38.2%) | 2,659/6,036 (44.1%) |
| Placebo | — | 2,341/6,052 (38.7%) | 2,529/6,052 (41.8%) |
| Event | Evacetrapib | Placebo |
|---|---|---|
| Angina unstableCardiac disorders | 298/6036 | 289/6052 |
| Percutaneous coronary interventionSurgical and medical procedures | 192/6036 | 182/6052 |
| Acute myocardial infarctionCardiac disorders | 146/6036 | 137/6052 |
| PneumoniaInfections and infestations | 115/6036 | 112/6052 |
| Non-cardiac chest painGeneral disorders | 107/6036 | 108/6052 |
| Cardiac failure congestiveCardiac disorders | 95/6036 | 103/6052 |
| Angina pectorisCardiac disorders | 102/6036 | 98/6052 |
| Myocardial infarctionCardiac disorders | 82/6036 | 100/6052 |
| Atrial fibrillationCardiac disorders | 86/6036 | 78/6052 |
| Coronary revascularisationSurgical and medical procedures | 82/6036 | 79/6052 |
| Event | Evacetrapib | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 472/6036 | 414/6052 |
| NasopharyngitisInfections and infestations | 452/6036 | 465/6052 |
| HypertensionVascular disorders | 453/6036 | 403/6052 |
| Back painMusculoskeletal and connective tissue disorders | 399/6036 | 379/6052 |
| DizzinessNervous system disorders | 389/6036 | 352/6052 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 375/6036 | 370/6052 |
| BronchitisInfections and infestations | 363/6036 | 375/6052 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 339/6036 | 329/6052 |
| Upper respiratory tract infectionInfections and infestations | 327/6036 | 327/6052 |
| CoughRespiratory, thoracic and mediastinal disorders | 327/6036 | 279/6052 |
| Age, Continuous(years) | Evacetrapib | Placebo | Total |
|---|---|---|---|
| Mean | 64.791 ± 9.3849 | 64.994 ± 9.4591 | 64.892 ± 9.4223 |
| Sex: Female, Male(Participants) | Evacetrapib | Placebo | Total |
|---|---|---|---|
| Female | 1390 | 1394 | 2784 |
| Male | 4648 | 4660 | 9308 |
| Ethnicity (NIH/OMB)(Participants) | Evacetrapib | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 500 | 522 | 1022 |
| Not Hispanic or Latino | 5394 | 5386 | 10780 |
| Unknown or Not Reported | 144 | 146 | 290 |
| Race (NIH/OMB)(Participants) | Evacetrapib | Placebo | Total |
|---|---|---|---|
| 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(Participants) | Evacetrapib | Placebo | Total |
|---|---|---|---|
| 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 |
Showing the first 100 of 444 sites across 37 countries.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
The record gives a start of Oct 2012, a primary completion of Mar 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
Results were first posted in May 2018, 2 years 2 months after primary completion. A results delay was requested in Aug 2016.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Evacetrapib