Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000608460
Ethics application status
Approved
Date submitted
18/04/2024
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose Titration Study: Assess the efficacy of dose titration in improving statin therapy following a heart attack
Scientific title
Evaluate the effects of dose titration of statin therapy following non-ST elevation myocardial infarction on reducing side effects and enhancing adherence through a randomized controlled trial.
Secondary ID [1] 311606 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non ST Elevation Myocardial Infarction 333597 0
Condition category
Condition code
Cardiovascular 330281 330281 0 0
Coronary heart disease
Cardiovascular 330282 330282 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves gradually adjusting the dose of statin medication for patients who have experienced a non-ST elevation myocardial infarction (NSTEMI). Starting with a lower dose, the medication will be titrated upward over time until the desired effect is achieved. This approach aims to minimize potential side effects associated with statin therapy while still providing the cardiovascular benefits.

The dose will be commenced at Atorvastatin 10mg daily and doubled every month for 4 months until a maximum dose of 80mg daily is obtained. 10mg daily for one month, 20mg daily for one month, 40mg daily for one month and 80m daily for one month.

The titrated dose will be continued for one month until a maximum dose is achieved and will be continued daily regularly

The administation will be an oral tablet

Drug adherence will be monitored by self reporting check list that will be provided to the patient that they can record when they have taken the medication and if they have any side effects and then a 6 monthly standard blood test will be done post their non ST elevation MI to assess lipid reduction (as per standard management protocol for NSTEMI)
Intervention code [1] 328445 0
Treatment: Drugs
Comparator / control treatment
The control group will receive standard statin therapy at a fixed dose of 80mg. They will not undergo dose titration like the experimental group. This allows for comparison of outcomes between patients receiving standard therapy and those undergoing dose titration.
Control group
Active

Outcomes
Primary outcome [1] 338024 0
Primary Outcome: The primary outcome of the study is the change in lipid levels from baseline to the end of the 6-month study period.
Timepoint [1] 338024 0
Primary Time Point: The primary time point for assessing the change in lipid levels will be at the end of the 6-month study period post enrollment
Secondary outcome [1] 434168 0
The secondary outcome of the study is patient adherence to statin therapy.
Timepoint [1] 434168 0
Secondary Time Point: The time point for assessing patient adherence will be at the end of the 6-month study period (post enrollment)

Eligibility
Key inclusion criteria
Key Inclusion Criteria:
1. Diagnosis of Non-ST Elevation Myocardial Infarction (NSTEMI)
2. Prescribed statin therapy as part of post-NSTEMI management
3. Ability to provide informed consent
4. Age 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key Exclusion Criteria:
1. History of statin intolerance or allergy
2. Inability to adhere to the study protocol or complete required assessments
3. Contraindication to statin therapy
4. Severe comorbidities or conditions affecting life expectancy
5. Participation in another clinical trial involving lipid-lowering medications

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)
allocation concealment involves using sealed envelopes prepared by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation employs computer-generated randomization by an impartial statistician.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2025
Actual
Date of last participant enrolment
Anticipated
19/09/2025
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315914 0
Hospital
Name [1] 315914 0
Sunshine Hospital, Western Health
Country [1] 315914 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Hospital, Western Health
Address
Country
Australia
Secondary sponsor category [1] 318064 0
None
Name [1] 318064 0
Address [1] 318064 0
Country [1] 318064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314760 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314760 0
Ethics committee country [1] 314760 0
Australia
Date submitted for ethics approval [1] 314760 0
17/08/2023
Approval date [1] 314760 0
01/11/2024
Ethics approval number [1] 314760 0

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

Contacts
Principal investigator
Name 132638 0
Dr Mohammed Warraich
Address 132638 0
Sunshine Hospital, Western Health 176 Furlong Rd, St Albans VIC 3021
Country 132638 0
Australia
Phone 132638 0
+61 424626297
Fax 132638 0
Email 132638 0
[email protected]
Contact person for public queries
Name 132639 0
Mohammed Warraich
Address 132639 0
Sunshine Hospital, Western Health 176 Furlong Rd, St Albans VIC 3021
Country 132639 0
Australia
Phone 132639 0
+61 424626297
Fax 132639 0
Email 132639 0
[email protected]
Contact person for scientific queries
Name 132640 0
Mohammed Warraich
Address 132640 0
Sunshine Hospital, Western Health 176 Furlong Rd, St Albans VIC 3021
Country 132640 0
Australia
Phone 132640 0
+61 424626297
Fax 132640 0
Email 132640 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This has been changed. It will only be shared with those apart of the study. I.e Supervisor and Statistician



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.