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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01042769




Registration number
NCT01042769
Ethics application status
Date submitted
5/01/2010
Date registered
6/01/2010
Date last updated
2/11/2016

Titles & IDs
Public title
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
Scientific title
A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
Secondary ID [1] 0 0
2009-012269-71
Secondary ID [2] 0 0
BC22140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aleglitazar
Treatment: Drugs - Placebo

Experimental: Aleglitazar -

Placebo comparator: Placebo -


Treatment: Drugs: Aleglitazar
aleglitazar 150 micrograms po daily

Treatment: Drugs: Placebo
placebo control po daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Timepoint [1] 0 0
Throughout study, approximately 4.5 years
Secondary outcome [1] 0 0
Effects on other cardiovascular endpoints
Timepoint [1] 0 0
Throughout study, approximately 4.5 years
Secondary outcome [2] 0 0
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk
Timepoint [2] 0 0
Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
Secondary outcome [3] 0 0
Tolerability and long-term safety profile
Timepoint [3] 0 0
Throughout study, approximately 4.5 years

Eligibility
Key inclusion criteria
* Adults >18 years of age
* Type 2 diabetes mellitus
* Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Estimated glomerular filtration rate <45 mL/min/1.73m2
* Concomitant treatment with a thiazolidinedione and/or fibrate
* Triglycerides >400 mg/dL
* Anaemia
* Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
7226
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Bankstown
Recruitment hospital [3] 0 0
- Concord
Recruitment hospital [4] 0 0
- Darlinghurst
Recruitment hospital [5] 0 0
- Liverpool BC
Recruitment hospital [6] 0 0
- New Lambton
Recruitment hospital [7] 0 0
- Penrith
Recruitment hospital [8] 0 0
- St. Leonards
Recruitment hospital [9] 0 0
- Sydney
Recruitment hospital [10] 0 0
- Wollongong
Recruitment hospital [11] 0 0
- Douglas
Recruitment hospital [12] 0 0
- Milton
Recruitment hospital [13] 0 0
- Redcliffe
Recruitment hospital [14] 0 0
- Southport
Recruitment hospital [15] 0 0
- Woolloongabba
Recruitment hospital [16] 0 0
- Adelaide
Recruitment hospital [17] 0 0
- Elizabeth Vale
Recruitment hospital [18] 0 0
- Woodville
Recruitment hospital [19] 0 0
- Ballarat
Recruitment hospital [20] 0 0
- Geelong
Recruitment hospital [21] 0 0
- Richmond
Recruitment hospital [22] 0 0
- Shepparton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
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2139 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
1871 - Liverpool BC
Recruitment postcode(s) [6] 0 0
2305 - New Lambton
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2751 - Penrith
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2065 - St. Leonards
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2217 - Sydney
Recruitment postcode(s) [10] 0 0
2500 - Wollongong
Recruitment postcode(s) [11] 0 0
4184 - Douglas
Recruitment postcode(s) [12] 0 0
4064 - Milton
Recruitment postcode(s) [13] 0 0
4020 - Redcliffe
Recruitment postcode(s) [14] 0 0
4215 - Southport
Recruitment postcode(s) [15] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [16] 0 0
5000 - Adelaide
Recruitment postcode(s) [17] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [18] 0 0
5011 - Woodville
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3353 - Ballarat
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3220 - Geelong
Recruitment postcode(s) [21] 0 0
3121 - Richmond
Recruitment postcode(s) [22] 0 0
3630 - Shepparton
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Wrexham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
Trial website
https://clinicaltrials.gov/study/NCT01042769
Trial related presentations / publications
Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.
Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.
Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.
Public notes

Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01042769