Cardiovascular outcomes · Phase 3
ELIXA: outcomes after an acute coronary event
What was tested?
Lixisenatide versus placebo added to usual care after a recent acute coronary event in people with type 2 diabetes. ↗
Registered primary question: Time to cardiovascular death, nonfatal heart attack, nonfatal stroke or hospitalization for unstable angina. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-15
The primary cardiovascular composite occurred in 13.4% versus 13.2%; hazard ratio 1.02 (95% CI 0.89–1.17). Noninferiority was met, superiority was not. Serious adverse events were not more frequent with lixisenatide.↗
Keep in context: The trial met its noninferiority criterion but did not show superiority. Its cardiovascular composite includes unstable-angina hospitalization, unlike some other trials in this collection. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 6,068 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Triple
- Design
- Parallel
- Eligible ages
- 30 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2016-12-20; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
ELIXA: cardiovascular outcomes
- Design in the report
- Randomized placebo-controlled trial added lixisenatide or placebo to usual care.↗
- Participants in the report
- 6,068 people with type 2 diabetes and a recent acute coronary event were followed for a median of 25 months.↗
- Limitations
- The result is a cardiovascular safety comparison in a high-risk population, not evidence of cardiovascular benefit or the entire glycemic-efficacy program.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) ↗
Protocol identifier: EFC11319. Sponsor: Sanofi.
Retrieved 2026-09-20; SHA-256 676f2a9e06fa6bd340b79dd02670590f8733bd72fe1bd15d99e7042cff0bd640.
PMID 26630143
Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. ↗
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 26630143. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 115be31c54d4952d6d390218d4c3015c727c520d819e34874e529579c32c2176.