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    Summary
    EudraCT Number:2012-000061-21
    Sponsor's Protocol Code Number:I1V-MC-EIAN
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-000061-21
    A.3Full title of the trial
    Protocol I1V-MC-EIAN Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes - the ACCELERATE Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to find out whether “Evacetrapib” can help patients who suffer from blockages in the blood vessels to their heart, brain, or legs who are at high risk for having a heart attack, stroke or may even die from the disease
    A.3.2Name or abbreviated title of the trial where available
    ACCELERATE
    A.4.1Sponsor's protocol code numberI1V-MC-EIAN
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEvacetrapib
    D.3.2Product code LY2484595
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number 1186486-62-3
    D.3.9.2Current sponsor codeLY2484595
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number130
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High Risk Vascular Disease (HRVD)
    E.1.1.1Medical condition in easily understood language
    High risk vascular disease includes patients with blockages in the blood vessels to their heart, brain or legs who are at high risk for having a heart attack, stroke or may even die from the disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10067825
    E.1.2Term Peripheral arterial disease
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10003602
    E.1.2Term Atherosclerosis cerebral
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, mycocardial infarction (MI), storke, coronary revascularization, or hospitalization for unstable angina (UA) in high-risk vascular disease (HRVD) patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to test the hypotheses that evacetrapib 130 mg daily, in HRVD patients compared to placebo:
    • Increases high-density lipoprotein-cholesterol (HDL-C) at 3 months after randomization
    • Decreases low-density lipoprotein-cholesterol (LDL-C) at 3 months after randomization
    Reduces the incidence of the following:
    • A composite endpoint of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for UA
    • Composite endpoint of CV death, MI, or coronary revascularization
    • Composite endpoint of CV death, MI, stroke, or hospitalization for UA
    • Composite endpoint of CV death, MI, or stroke
    • Recurrence of any component of the primary composite endpoint among those who had already reached the primary endpoint
    • Coronary revascularization
    • MI
    • CV death
    • All-cause mortality
    • Hospitalization for UA
    • Stroke
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with HRVD are defined by at least 1 of the following 4 groups. Note that an eligible patient may meet inclusion criteria for more than 1 group.
    1) History of ACS (that is, ≥30 days through 365 days after discharge for ACS)
    For the purposes of this study, ACS will include 1) unstable angina and non-ST-segment elevation myocardial
    infarction [UA/NSTEMI] and 2) ST-segment elevation myocardial infarction [STEMI] as follows:
    • UA is defined as a history of chest discomfort or ischemic symptoms of ≥10 minutes duration at rest with persistent or transient ST-segment deviation ≥1 mm in 1 or more electrocardiogram (ECG) leads without elevation of creatine kinase-myocardial bands (CK-MB) or troponin T or I.
    • NSTEMI is defined as a history of chest discomfort or ischemic symptoms of ≥10 minutes duration at rest with no evidence of persistent ST-segment elevation. Patients must also have CK-MB or troponin T or I greater than the 99th percentile upper reference limit or the upper limit of normal (ULN). If CK-MB or troponin is not available, total CK greater than 99th percentile upper reference limit (or ULN) is acceptable.
    • STEMI is defined as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest with 1 of the following present on at least 1 electrocardiogram (ECG) prior to randomization:
    1. ST-segment elevation ≥1 mm in 2 or more contiguous ECG leads
    2. New or presumably new left bundle branch block (LBBB)
    3. ST-segment depression ≥1 mm in 2 anterior precordial leads with clinical history and evidence suggestive of true posterior infarction
    Patients will have either undergone successful coronary revascularization associated with the ACS event prior to date of anticipated randomization or are not anticipated to undergo coronary revascularization.
    Patients will NOT qualify for the trial on the basis of MI related to revascularization intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) performed outside the setting of an acute ACS.
    2) Cerebrovascular Atherosclerotic Disease
    • History of transient ischemic attack (TIA) or ischemic stroke (≥30 days) with carotid stenosis ≥50% in the distribution of the clinical event, or
    • Asymptomatic carotid artery stenosis ≥70%, or
    • A history of carotid artery revascularization
    3) Peripheral Arterial Disease
    Peripheral arterial disease (PAD) for this study will be defined as current intermittent claudication or resting limb ischemia and either an ankle-brachial index (ABI) ≤0.90, or a history of atherosclerotic limb ischemia leading to previous noncoronary revascularization or amputation.
    Patients will NOT qualify for the trial on the basis of isolated renal artery stenosis in the absence of other inclusion criteria.
    4) Diabetes Mellitus with Documented Coronary Artery Disease
    Diabetes mellitus (DM) patients are defined as either receiving concomitant treatment with an oral or parenteral hypoglycemic agent and/or insulin, or being managed by diet alone, as a result of a preexisting diagnosis of DM. A new diagnosis is based on plasma glucose measurements or glycated hemoglobin (HbA1c) levels (with anticipated treatment with an oral or parenteral hypoglycemic agent and/or insulin, or to be managed by diet alone). Patients with DM must have CAD documented by a previous MI, PCI, CABG, or >50% angiographic stenosis of ≥1 major coronary artery.
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] Males or females ≥18 years of age with a diagnosis of HRVD (that is, meet at least 1 of the disease
    diagnostic criteria described above), and are clinically stable (as judged by the responsible physician)
    [2] Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin, patients must have documented statin intolerance, or contraindication to statin (as defined in the protocol)
    [3] Have a screening HDL-C ≤80 mg/dL (≤2.1 mmol/L)
    [4] Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)
    [5] Meet 1 of the following criteria:
    a) screening LDL-C no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L])
    OR
    b) if LDL-C is greater than target, the patient must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin
    [6] At the time of screening, are able and willing to give written informed consent
    E.4Principal exclusion criteria
    General Exclusion Criteria
    [7] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
    [8] Are Lilly employees or are employees of the Academic Research Organization (ARO) or Clinical Research Organization (CRO) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical studies but are not permitted to participate at a Lilly facility. Immediate family is defined above
    [9] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
    [10] Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
    Medical Conditions Exclusion Criteria
    [11] Females who are known to be pregnant
    [12] Females who are breastfeeding
    [13] Women of child-bearing potential only (that is, women who are not surgically or chemically sterilized and who are between menarche and 1 year postmenopause), who test positive for pregnancy between screening and randomization (based on the required urine or serum pregnancy test) or who do not agree to use a reliable method of birth control during the study
    [14] History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days
    [15] Any reading of systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg at screening or randomization
    [16] History of hemorrhagic stroke or intracranial hemorrhage
    [17] New York Heart Association class III or IV congestive heart failure
    [18] Serum creatinine >2.2 mg/dL (>194.5 μmol/L) at screening
    [19] Clinically active liver disease (for example, esophageal varices, jaundice, ascites, cholestasis, acute or chronic hepatitis). Patients are not excluded due to Gilbert’s Syndrome or a history of cholelythiasis/cholecystectomy
    [20] History of malignancy (except for nonmelanoma skin cancer/basal cell or squamous cell carcinoma of the skin) within the preceding 3 years prior to screening
    [21] Known malabsorption syndrome with the exception of lactose intolerance
    [22] Patients with a known history of primary or secondary hyperaldosteronism
    [23] Patients with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
    [24] Any clinically significant medical condition that according to the investigator could interfere with participation in the study
    [25] Patients whose life expectancy is anticipated to be less than 4 years
    [26] Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study
    [27] Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator
    Prior/Concomitant Therapy Exclusion Criteria
    [28] Concurrent or anticipated need for treatment with niacin >250 mg/day
    [29] Concurrent or anticipated need for chronic administration of drugs on the exclusion list
    [30] Previous exposure to (or participation in a trial of) the CETP inhibitors dalcetrapib or evacetrapib within the last 3 months or anacetrapib within the last 12 months.
    Procedure Exclusion Criteria
    [31] Any planned coronary angiography or coronary revascularization procedure. If angiography or revascularization is planned, patients may be screened and enrolled after all such planned procedures are completed
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of any component of the composite cardiovascular (CV) events of death, myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina (UA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until all of the following criteria are satisfied: 1) at least 1136 patients experience 1 or more components of the primary composite endpoint of CV death, MI, stroke, coronary revascularization, or hospitalization for UA; 2) at least 500 patients experience 1 or more components of the composite endpoint of CV death, MI, or stroke; 3) at least 1.5 years have elapsed from the date of last patient randomized
    E.5.2Secondary end point(s)
    Compared to placebo:
    -Percent change from baseline of mean HDL-C levels at 3 months after randomization
    -Percent change from baseline of mean LDL-C levels at 3 months after randomization
    Time to first occurrence of:
    -A composite endpoint of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for UA
    -Composite endpoint of CV death, MI, or coronary revascularization
    - Composite endpoint of CV death, MI, stroke, or hospitalization for UA
    - Composite endpoint of CV death, MI, or stroke
    Time to first recurrence of:
    - Any component of the primary composite endpoint among those who had already reached the primary endpoint
    Time to first occurrence of:
    -Coronary revascularization
    -MI
    Time to:
    -CV death
    - All-cause mortality
    Time to first occurrence of:
    - Hospitalization for UA
    - Stroke
    E.5.2.1Timepoint(s) of evaluation of this end point
    HDL-C and LDL-C are evaluated at 3 months after randomization.

    The other Secondary endpoints are event driven
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA141
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Democratic People's Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Peru
    Poland
    Puerto Rico
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3850
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state117
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3588
    F.4.2.2In the whole clinical trial 11000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Study drug will not be made available at the conclusion of the study. Patients will be referred totheir local treatment centers for continued therapy as clinically indicated.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-12
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