Study S001991

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01147250
Acronym: ELIXA
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: COMPLETED
Enrollment: 6068
Start: 2010-06
Primary completion: 2015-02
Lead sponsor: Sanofi
Conditions: Acute Coronary Syndrome
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2009-012852-26; OTHER:U1111-1116-5558; NIH:2009

Registered primary outcomes

Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina [From randomization up to the end of study (median follow-up of 25 months)]

Linked records (15)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:39963952
R0020869	Effect of lixisenatide on natriuretic peptides in people with type 2 diabetes and recent acute coronary syndrome: The ELIXA trial. Gerstein HC, Diabetes, obesity & metabolism	2023	Other trial	PMID 36546588 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:36546588
R0024708	Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Gerstein HC, Diabetes care	2022	Other trial	PMID 35817031 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:35817031
R0054195	162-LB: Cardiovascular Outcomes in People with Type 2 Diabetes and Acute Coronary Syndrome—The ELIXA Biomarker Study Hertzel C. Gerstein, Diabetes	2022	Other trial	DOI	cites ClinicalTrials.gov:NCT01147250
R0026961	Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Wijkman MO, Cardiovascular diabetology	2020	Randomized trial	PMID 33046070 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:33046070
R0053309	1421-P: The Impact of Blood Pressure on Risk of Death Is Influenced by Prior Cardiovascular Disease in Patients with Type 2 Diabetes and a Recent Coronary Event Magnus Olof Wijkman, Diabetes	2020	Other trial	DOI	cites ClinicalTrials.gov:NCT01147250
R0007117	Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Wittbrodt ET, The American journal of managed care	2018	Nonrandomized study	PMID 29693361	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:29693361
R0016210	Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Muskiet MHA, The lancet. Diabetes & endocrinology	2018	Randomized trial	PMID 30292589 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:30292589
R0026424	Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. Seferovic JP, Journal of diabetes research	2018	Randomized trial	PMID 30648112 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:30648112
R0049736	Implications of cardiovascular outcome trials with injectable antidiabetic agents Richard E. Pratley, Journal of Diabetes	2018	Randomized trial	PMID 29971941 DOI	cites ClinicalTrials.gov:NCT01147250
R0028699	Increases in Natriuretic Peptides Precede Heart Failure Hospitalization in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. Wolsk E, Circulation	2017	Randomized trial	PMID 29038210 DOI	cites ClinicalTrials.gov:NCT01147250
R0028721	Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. Wolsk E, Journal of the American Heart Association	2017	Other trial	PMID 28554908 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:28554908
R0012831	Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Bentley-Lewis R, American heart journal	2015	Randomized trial	PMID 25965710 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference BACKGROUND:25965710
R0015384	Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. Pfeffer MA, The New England journal of medicine	2015	Randomized trial	PMID 26630143 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference RESULT:26630143
R0022649	Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. Wohlfart P, Journal of translational medicine	2013	Randomized trial	PMID 23537041 DOI	cites ClinicalTrials.gov:NCT01147250; registry reference DERIVED:23537041