A Phase 3 interventional study of Lixisenatide (AVE0010) and Placebo in Acute Coronary Syndrome, sponsored by Sanofi. Completed at 829 sites in 49 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
To demonstrate that when compared to placebo, lixisenatide can reduce:
To assess the safety and tolerability of lixisenatide.
The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down as follows:
All participants were followed from randomization until the end of study, which should occur when the last randomized participant had been followed for approximately 10 months. The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 6,068 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Placebo matched to lixisenatide once daily (QD) up to end of treatment.
Drug: Placebo
Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.
Drug: Lixisenatide (AVE0010)
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.
Also known as: Lyxumia
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.
Time frame: From randomization up to the end of study (median follow-up of 25 months)
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.
Time frame: From randomization up to the end of study (median follow-up of 25 months)
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure
All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.
Time frame: From randomization up to the end of study (median follow-up of 25 months)
Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108
Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.
Time frame: Baseline to Week 108 (LOCF)
The study was conducted at 829 centers in 49 countries. A total of 7719 participants were screened between June 24, 2010 and July 24, 2013. 1651 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.
| Milestone | Placebo | Lixisenatide |
|---|---|---|
| Started | 3034 | 3034 |
| Treated | 3032 | 3031 |
| Completed | 2924 | 2929 |
| Not completed | 110 | 105 |
| Withdrew: Lost to follow-up | 14 | 11 |
| Withdrew: Withdrawal by subject | 83 | 88 |
| Withdrew: Site termination by sponsor | 13 | 5 |
| Withdrew: Other than specified | 0 | 1 |
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.
| participants | Placebo | Lixisenatide |
|---|---|---|
| Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina | 399 | 406 |
All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.
| participants | Placebo | Lixisenatide |
|---|---|---|
| Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure | 469 | 456 |
All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.
| participants | Placebo | Lixisenatide |
|---|---|---|
| Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure | 659 | 661 |
Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.
| percent change | Placebo | Lixisenatide |
|---|---|---|
| Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108 | 34.21 ± 3.09 | 24.17 ± 2.84 |
Collected over All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 669/3,032 (22.1%) | 1,270/3,032 (41.9%) |
| Lixisenatide | — | 625/3,031 (20.6%) | 1,597/3,031 (52.7%) |
| Event | Placebo | Lixisenatide |
|---|---|---|
| PneumoniaInfections and infestations | 51/3032 | 36/3031 |
| Non-cardiac chest painGeneral disorders | 42/3032 | 46/3031 |
| Atrial fibrillationCardiac disorders | 30/3032 | 23/3031 |
| Angina pectorisCardiac disorders | 23/3032 | 23/3031 |
| Renal failure acuteRenal and urinary disorders | 20/3032 | 20/3031 |
| Urinary tract infectionInfections and infestations | 19/3032 | 18/3031 |
| CellulitisInfections and infestations | 18/3032 | 17/3031 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 18/3032 | 8/3031 |
| SyncopeNervous system disorders | 16/3032 | 16/3031 |
| Hypertensive crisisVascular disorders | 13/3032 | 15/3031 |
| Event | Placebo | Lixisenatide |
|---|---|---|
| NauseaGastrointestinal disorders | 179/3032 | 659/3031 |
| HypoglycaemiaMetabolism and nutrition disorders | 554/3032 | 609/3031 |
| DizzinessNervous system disorders | 191/3032 | 259/3031 |
| VomitingGastrointestinal disorders | 82/3032 | 257/3031 |
| DiarrhoeaGastrointestinal disorders | 227/3032 | 237/3031 |
| Angina pectorisCardiac disorders | 200/3032 | 177/3031 |
| NasopharyngitisInfections and infestations | 188/3032 | 181/3031 |
| HeadacheNervous system disorders | 148/3032 | 187/3031 |
| HypertensionVascular disorders | 171/3032 | 152/3031 |
| Non-cardiac chest painGeneral disorders | 171/3032 | 137/3031 |
| Age, Continuous(years) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Mean | 60.6 ± 9.6 | 59.9 ± 9.7 | 60.3 ± 9.7 |
| Gender(Participants) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Female | 938 | 923 | 1861 |
| Male | 2096 | 2111 | 4207 |
| Race(participants) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Caucasian/White | 2318 | 2258 | 4576 |
| Black | 103 | 118 | 221 |
| Asian/Oriental | 367 | 404 | 771 |
| Other | 246 | 254 | 500 |
| Ethnicity(participants) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Hispanic | 903 | 865 | 1768 |
| Not Hispanic | 2131 | 2169 | 4300 |
| Qualifying Acute Coronary Syndrome (ACS) event(participants) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| ST-segment elevation myocardial infarction (MI) | 1317 | 1349 | 2666 |
| Non ST-segment elevation MI | 1183 | 1165 | 2348 |
| Unstable angina | 528 | 514 | 1042 |
| Unclassified | 4 | 5 | 9 |
| Not qualifying ACS event | 2 | 1 | 3 |
| Body Mass Index (BMI)(kg/m^2) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Mean | 30.2 ± 5.79 | 30.12 ± 5.6 | 30.16 ± 5.69 |
| Body Weight(kg) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Mean | 85.06 ± 19.64 | 84.64 ± 19.21 | 84.85 ± 19.43 |
| Glycosylated Hemoglobin (HbA1c)(Percentage of HbA1c) | Placebo | Lixisenatide | Total |
|---|---|---|---|
| Mean | 7.64 ± 1.28 | 7.72 ± 1.32 | 7.68 ± 1.30 |
1 further baseline measures are reported on the registry.
Showing the first 100 of 829 sites across 49 countries.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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