Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000003572
Ethics application status
Approved
Date submitted
21/12/2005
Date registered
4/01/2006
Date last updated
4/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of ramipril on platelet responsiveness to nitric oxide donors.A randomised,placebo controlled, double blind study in patients with high cardiovascular risk.
Scientific title
Effects of ramipril on platelet responsiveness to nitric oxide donors.A randomised,placebo controlled, double blind study in patients with high cardiovascular risk.
Secondary ID [1] 229 0
Aventis pharmaceuticals
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High cardiovascular risk 964 0
Condition category
Condition code
Cardiovascular 1036 1036 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ramipril 10mg for 12 weeks
Intervention code [1] 812 0
Treatment: Drugs
Comparator / control treatment
Placebo for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 1386 0
Changes in platelet responsiveness to SNP
Timepoint [1] 1386 0
After 12 weeks of ramipril therapy
Secondary outcome [1] 2450 0
Effects of ACE inhibitors on arterial compliance.
Timepoint [1] 2450 0
Secondary outcome [2] 2451 0
Effects of ACE inhibitors on platelet reponsiveness to SNP.
Timepoint [2] 2451 0
After 4 weeks.
Secondary outcome [3] 2452 0
Effects of ACE inhibitors on measures of oxidative stress.
Timepoint [3] 2452 0

Eligibility
Key inclusion criteria
Have pmh of CAD,PVD or stroke or who have diabetes plus at least 1 CV risk(HOPE).
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ACE or ARB therapy or need to start same or contraindications to same.Less than 2 Ohms of ADP induced platelet aggregation at baseline.

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)
Unblinded pharmacist used for treatment allocation.Numbered containers were allocated to patients via fax to central pharmacist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated via computer in permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1136 0
Commercial sector/Industry
Name [1] 1136 0
Aventis pharmaceuticals
Country [1] 1136 0
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital Cardiology Department
Address
Country
United Kingdom
Secondary sponsor category [1] 993 0
None
Name [1] 993 0
NA
Address [1] 993 0
Country [1] 993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2448 0
The Queen Elizabeth Hospital
Ethics committee address [1] 2448 0
Ethics committee country [1] 2448 0
Australia
Date submitted for ethics approval [1] 2448 0
Approval date [1] 2448 0
Ethics approval number [1] 2448 0

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

Contacts
Principal investigator
Name 35688 0
Address 35688 0
Country 35688 0
Phone 35688 0
Fax 35688 0
Email 35688 0
Contact person for public queries
Name 10001 0
Sue Leslie
Address 10001 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 10001 0
Australia
Phone 10001 0
+61 8 82226000
Fax 10001 0
+61 8 82227021
Email 10001 0
sue.leslie@nwahs.sa.gov.au
Contact person for scientific queries
Name 929 0
Professor John Horowitz
Address 929 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 929 0
Australia
Phone 929 0
+61 8 82226000
Fax 929 0
+61 8 82227021
Email 929 0
sue.lesie@nwahs.sa.gov.au

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.