Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000575730
Ethics application status
Approved
Date submitted
20/05/2013
Date registered
21/05/2013
Date last updated
23/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of low- vs. high-dose Rosuvastatin in minor heart attack patients and healthy controls: assessment of skin microvascular blood flow.
Scientific title
Does one week of 10mg vs. 40mg Rosuvastatin improve skin microvascular blood flow in stable non-ST segment elevation myocardial infarction (NSTEMI) and healthy controls? A pilot study.
Secondary ID [1] 282531 0
None
Universal Trial Number (UTN)
U1111-1143-2824
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral microvascular dysfunction in non-ST segment elevation myocardial infarction (NSTEMI). 289196 0
Condition category
Condition code
Cardiovascular 289522 289522 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40mg Rosuvastatin (Crestor) tablet administered orally once daily in the morning for 7 days. Drug tablet return will be used to monitor adherence.
Intervention code [1] 287193 0
Treatment: Drugs
Comparator / control treatment
10mg Rosuvastatin (Crestor) tablet administered orally once daily in the morning for 7 days. Drug tablet return will be used to monitor adherence.
Control group
Dose comparison

Outcomes
Primary outcome [1] 289620 0
Change in peripheral subcutaenous microvascular reactivity as assessed by laser Doppler flowmetry.
Timepoint [1] 289620 0
After 7 days Rosuvastatin treatment.
Secondary outcome [1] 302880 0
Percent change in blood low-density lipoprotein (LDL) levels.
Timepoint [1] 302880 0
After 7 days Rosuvastatin treatment.

Eligibility
Key inclusion criteria
Post-menopausal women (STRAW +10 definition) and age-matched men

NSTEMI group only - Evidence of NSTEMI: Electrocardiographic ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent)
Minimum age
55 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current statin therapy
Skin pathology on volar forearms
Previous myocardial infarction or coronary artery bypass grafting
Known serious or hypersensitivity reactions to statin, anti-platelet agents (aspirin or clopidogrel), or heparin
Cardiogenic shock or symptomatic hypotension or sitting SBP < 95mmHg
Congestive heart failure (NYHA Class III or IV) or LVEF < 35%
Inability to provide informed consent
Non-English speaking

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)
Healthy controls will be approached personally and privately. The study will be explained and suitability assessed prior to consent.
Suitable NSTEMI patients will be consented after referral from the chest pain assessment team and treating medical staff.
After baseline microvascular reactivity assessment, participants are randomised to 10mg or 40mg Rosuvastatin using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation, stratified according to gender with equal numbers of males and females in each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between groups will be analysed using the Student’s T-test, Mann Whitney U-test or Fisher’s exact test as appropriate. Correlations will be assessed using Pearson’s Product Moment Correlation. Differences in iontophoresis response curves between groups will be assessed using generalized equalizing equations (GEEs). A probability value of P<0.05 will be considered statistically significant.
A power calculation was not performed because this is a pilot study. The data generated from this study will provide an indication of sample size for future studies.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/01/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1039 0
Lyell McEwin Hospital - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 287314 0
Charities/Societies/Foundations
Name [1] 287314 0
Tom Simpson Trust Fund
Country [1] 287314 0
Australia
Funding source category [2] 287315 0
University
Name [2] 287315 0
University of Adelaide-Lyell McEwin Hospital Strategic Initiative Fund
Country [2] 287315 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Hosptial Department of Cardiology
Address
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale Sa 5112
Country
Australia
Secondary sponsor category [1] 286064 0
None
Name [1] 286064 0
Address [1] 286064 0
Country [1] 286064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289288 0
Human Research Ethics Committee (TQEH/LMH/MH) EC00190
Ethics committee address [1] 289288 0
The Queen Elizabeth Hospital
Ethics: DX465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 289288 0
Australia
Date submitted for ethics approval [1] 289288 0
22/05/2013
Approval date [1] 289288 0
20/09/2013
Ethics approval number [1] 289288 0

Summary
Brief summary
The cardiovascular system is made up of the heart, blood vessels and blood, and is responsible for the delivery of nutrients and removal of waste from the body. Blood flow is primarily regulated by the very small blood vessels. Examination of the skin blood vessels using laser Doppler flowmetry is an easy method that provides an index of global microvasculature function.

Statins are a class of drug that reduce cardiovascular events and mortality. In addition to lowering cholesterol levels, statins demonstrate a number of other effects that protect the heart. After a heart attack, statins improve patient outcomes by improving the function of the large and small blood vessels. Rosuvastatin is more potent and effective than other statins. However, no studies have investigated the effect of Rosuvastatin on the very small skin blood vessels in patients who have had a minor heart attack.

This pilot study aims to evaluate the effect of 1-week low- vs. high-dose Rosuvastatin therapy on very small blood vessel function in patients who present with a minor heart attack compared to a healthy population.
We hypothesise that 1-week high-dose Rosuvastatin in minor heart attack patients and healthy controls does not improve the function of the very small blood vessels when compared to 1-week low-dose Rosuvastatin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40178 0
Dr Sharmalar Rajendran
Address 40178 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 40178 0
Australia
Phone 40178 0
+61 4 3238 5589
Fax 40178 0
Email 40178 0
[email protected]
Contact person for public queries
Name 40179 0
Dr Sharmalar Rajendran
Address 40179 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 40179 0
Australia
Phone 40179 0
+61 4 3238 5589
Fax 40179 0
Email 40179 0
[email protected]
Contact person for scientific queries
Name 40180 0
Dr Sharmalar Rajendran
Address 40180 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 40180 0
Australia
Phone 40180 0
+61 4 3238 5589
Fax 40180 0
Email 40180 0
[email protected]

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.