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Trial registered on ANZCTR


Registration number
ACTRN12607000333415
Ethics application status
Approved
Date submitted
14/06/2007
Date registered
21/06/2007
Date last updated
6/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Long term impact of RAS inhibition on cardio-renal outcomes: a comparative trial of angiotensin converting enzyme inhibitors, angiotensin receptor blockers or combined therapy with both agents in patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic.
Scientific title
In patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic, administration of angiotensin converting enzyme inhibitors, angiotensin receptor blockers or combined therapy with both agents, comparison of three arms to assess the impact on cardiovascular and cerebrovascular outcomes.
Universal Trial Number (UTN)
Trial acronym
LIRICO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic. 1882 0
Condition category
Condition code
Cardiovascular 1976 1976 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 1977 1977 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACE-inhibitor (ACEi) monotherapy or angiotensin II receptor blocker (ARB) monotherapy or combined treatment with ACEi + ARB. Physicians will able to choose any commercially available ACEi or ARB of ACEi or ARB commercially available provided a blood pressure target of <130/80 mmHg is addressed.

The dose depends on the drug(s) selected by the investigator; the administration is by mouth (per os).
Duration of intervention/s: daily for the duration of the trial (4 years).
It is not possible to define a standard dose: the randomization decides which drug class will be assigned; the investigators must choose one of the drugs included in the class. The dose will be the standard dose of the selected drug. Therefore as the investigators can choose among about 85 ACEi and 36 ARB, it is not possible to define a standard dose.
Intervention code [1] 1828 0
Prevention
Comparator / control treatment
The controls are the two monotherapies.
Control group
Active

Outcomes
Primary outcome [1] 2796 0
To evaluate the comparative efficacy for cardiovascular and cerebrovascular outcomes of combined therapy with angiotensin converting enzyme inhibitors (ACEi) and (angiotensin receptor blockers) ARB versus monotherapy with ACEi or ARB in individuals with micro/macroalbuminuria and cardio-renal risk.
Timepoint [1] 2796 0
Every follow up visit (1, 3 and 6 months after randomization and then every six months).
Primary outcome [2] 2797 0
To evaluate the comparative efficacy for cardiac and cerebrovascular outcomes of ACEi monotherapy versus ARB monotherapy in the same individuals with micro/macroalbuminuria and cardio-renal risk.
Timepoint [2] 2797 0
Every follow up visit (1, 3 and 6 months after randomization and then every six months).
Secondary outcome [1] 4716 0
To evaluate the comparative efficacy for renal outcomes of combined therapy with angiotensin converting enzyme inhibitors (ACEi) and (angiotensin receptor blockers) ARB versus monotherapy with ACEi or ARB in individuals with micro/macroalbuminuria and cardio-renal risk.
Timepoint [1] 4716 0
Every follow up visit (1, 3 and 6 months after randomization and then every six months).
Secondary outcome [2] 4717 0
To evaluate the comparative efficacy for renal outcomes of ACEi monotherapy versus ARB monotherapy in the same individuals with micro/macroalbuminuria and cardio-renal risk.
Timepoint [2] 4717 0
Every follow up visit (1, 3 and 6 months after randomization and then every six months).

Eligibility
Key inclusion criteria
Consenting individuals, with microalbuminuria or macroalbuminuria, with one or more cardiovascular risk factors (smoking, diabetes, hypertension, visceral obesity, dyslipidemia, family history of cardiovascular diseases) including those with previous major cardiovascular events provided these have occurred at least 6 months before enrolment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, no use of birth control measures, neoplasm, clinically significant aortic obstruction, previous evidence of intolerance to study medications, clear contraindications to use of RAS inhibition, major cardiovascular events within 6 months of randomization, any condition which significantly reduces life expectancy and any condition where the patient appears not to be able to guarantee compliance with treatment and follow-up.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified allocation. The centres are used for the stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2100
Accrual to date
Final
Recruitment outside Australia
Country [1] 522 0
Italy
State/province [1] 522 0

Funding & Sponsors
Funding source category [1] 2119 0
Government body
Name [1] 2119 0
Italian Ministry of Health
Country [1] 2119 0
Italy
Primary sponsor type
Other
Name
Consorzio Mario Negri Sud
Address
Via Nazionale 8/a
66030 Santa Maria Imbaro (CH)- Italy
Country
Italy
Secondary sponsor category [1] 1925 0
None
Name [1] 1925 0
no one
Address [1] 1925 0
Country [1] 1925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3909 0
Ethic Committee of Bari polyclinic-Bari Polyclinic
Ethics committee address [1] 3909 0
Ethics committee country [1] 3909 0
ITALY
Date submitted for ethics approval [1] 3909 0
Approval date [1] 3909 0
05/03/2007
Ethics approval number [1] 3909 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27642 0
Address 27642 0
Country 27642 0
Phone 27642 0
Fax 27642 0
Email 27642 0
Contact person for public queries
Name 11017 0
Maria Celeste Pirozzoli
Address 11017 0
Dpt. Clinical Pharmacology and Epidemiology
Consorzio Mario Negri Sud
Via Nazionale 8/a
66030 Santa Maria Imbaro (CH)-
Country 11017 0
Italy
Phone 11017 0
+39 0872 570311
Fax 11017 0
+39 0872 570263
Email 11017 0
pirozzoli@negrisud.it
Contact person for scientific queries
Name 1945 0
Giovanni Strippoli
Address 1945 0
Dpt. Clinical Pharmacology and Epidemiology
Consorzio Mario Negri Sud
Via Nazionale 8/a
66030 Santa Maria Imbaro (CH)-
Country 1945 0
Italy
Phone 1945 0
+39 0872 570356
Fax 1945 0
+39 0872 570263
Email 1945 0
strippoli@negrisud.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.