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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05180942




Registration number
NCT05180942
Ethics application status
Date submitted
11/11/2021
Date registered
6/01/2022
Date last updated
25/03/2024

Titles & IDs
Public title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Scientific title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Secondary ID [1] 0 0
SOCRATES
Universal Trial Number (UTN)
Trial acronym
SOCRATES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Atherosclerosis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin Calcium 40Mg Tab

Experimental: Statin treatment - Atorvastatin 40mg, daily, orally for 18 months

No Intervention: No statin treatment - No comparator treatment/placebo allocated


Treatment: Drugs: Atorvastatin Calcium 40Mg Tab
One tablet daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in non-calcified plaque volume according to treatment with statins
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Change in total plaque volume in patients treated with ICI compared to historical cohorts
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Change in pericoronary adipose tissue attenuation and volume according to treatment with statins
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Cost-effectiveness of the use of CTCA as measured by net costs per life year gained in patients with melanoma treated with ICI therapy
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Incidence of adverse events with statin therapy
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Cost-effectiveness of statin therapy in patients with melanoma treated with ICI therapy as measured by net costs per life year gained
Timepoint [5] 0 0
18 months
Secondary outcome [6] 0 0
Effect of statins on depression in patients with melanoma treated with ICI therapy as measured on the Patient Health Questionnaire-9
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Effect of statins on anxiety in patients with melanoma treated with ICI therapy as measured on the Generalized Anxiety Disorder-7 questionnaire
Timepoint [7] 0 0
18 months
Secondary outcome [8] 0 0
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire
Timepoint [8] 0 0
18 months
Secondary outcome [9] 0 0
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the EuroQoL Group EQ-5D questionnaire
Timepoint [9] 0 0
18 months
Secondary outcome [10] 0 0
Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the FACT-M questionnaire
Timepoint [10] 0 0
18 months

Eligibility
Key inclusion criteria
- patients aged > or equal to 40 years

- historical or current diagnosis of stage 2, 3 or 4 melanoma treated with an ICI

- not currently treated with a statin ,and

- having acceptable imaging quality deemed by the core laboratory
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- inability to provide informed consent

- unwilling to be followed for serial evaluation

- contra-indication or intolerance to statins

- clinically manifest CV disease

- prognostic factors associated with an expected survival less than 18 months

- severe liver disease or advanced renal disease (³stage 3b CKD or eGFR <45 ml/min)

- any other factor that will preclude patients from participating in all study related
activities

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Cabrini Health - Malvern
Recruitment hospital [3] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3844 - Traralgon

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will incorporate a prospective randomised open blinded end-point trial in
participants with stage 2, 3 or 4 melanoma treated with ICI to evaluate the impact of statin
therapy on changes in coronary plaque burden and composition.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05180942
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen J Nicholls, MBBS, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Butters
Address 0 0
Country 0 0
Phone 0 0
+61434679018
Fax 0 0
Email 0 0
julie.butters@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05180942