Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000189628
Ethics application status
Approved
Date submitted
31/01/2014
Date registered
21/02/2014
Date last updated
24/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effect of an anti-platelet intervention with Ticagrelor versus placebo on participants with asymptomatic elevations in troponin T
Scientific title
Comparison of the effect of an anti-platelet approach with Ticagrelor versus placebo on asymptomatic elevations in troponin T
Secondary ID [1] 284019 0
The Asymptomatic HS-Troponin Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asymptomatic elevated troponin 291057 0
Condition category
Condition code
Cardiovascular 291400 291400 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Half the patients will take Ticagrelor 90mg twice daily, orally for 12 months. Each patient will be given enough supply until there next appointment, where by they will be asked to return the unused supply before receiving their next supply. At this point the returned bottles will be checked to confirm their self administration of medication correctly.
Intervention code [1] 288705 0
Treatment: Drugs
Intervention code [2] 288820 0
Prevention
Comparator / control treatment
Half the patients will take placebo twice daily, orally for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 291392 0
The primary outcome will be the change in troponin T level compared with baseline as measured by the Roche Elecsys high-sensitivity troponin assay.
Timepoint [1] 291392 0
6 months after randomisation.
Secondary outcome [1] 306657 0
Change in troponin T level compared with baseline as measured by the Roche high-sensitivity troponin assay.
Timepoint [1] 306657 0
3 months after randomisation.
Secondary outcome [2] 306658 0
Safety outcomes including significant bleeding using BARC primarily, plus GUSTO, TIMI and ACUITY definitions.
Timepoint [2] 306658 0
3, 6, and 12 months after randomisation.
Secondary outcome [3] 306660 0
Clinical outcomes including cardiovascular mortality, myocardial infarction using the Universal Definition of MI, and unplanned hospital admission for: non-elective coronary revascularisation (PCI or CABG), cerebrovascular accidents with cerebral imaging, atrial or ventricular arrhythmias, CCF without MI, and peripheral revascularisation as documented by a hospital discharge summary or diagnosis-related group report.
Timepoint [3] 306660 0
Up to 12 months after randomisation.

Eligibility
Key inclusion criteria
1. Patients discharged from the emergency department or from hospital without an Acute Coronary Syndrome diagnosis but with an elevated high sensitivity (HS) troponin T level 5-150pg/mL; and
2. At least one of the following high risk features:
-Diabetes: defined by current medical therapy for diabetes or an HbA1C of >6.5% within the last 6 months.
-Renal impairment: defined as a eGFR of 15-60ml/min/1.73m2 within the last 6 months
-Patients with an absolute risk of greater than 7.5% for a CVD over the next 5 years using a Framingham risk equation or the Australian Absolute risk calculator.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age >85 years.
2. Patients with indication for antiplatelet therapy: a) any prior history of acute coronary syndrome or stable angina with documented coronary stenosis >50% on coronary angiography or CT coronary angiography at any time in the past, b) any prior coronary revascularisation (CABG and PCI), c) documented peripheral vascular disease ie. a history of intermittent claudication or peripheral vascular intervention, d) any prior history of TIA or stroke.
3. Requirement for concomitant warfarin or other anticoagulant or antiplatelet therapy.
4. Unable to return for follow-up visits and repeat troponin assessment.
5. Increased risk of bleeding: anaemia with haemoglobin <10g/dl, active peptic ulcer disease, bleeding diathesis, elevated HAS-BLED Score greater than or equal to 3
6. Renal dysfunction with creatinine clearance of <15ml/min/1.73m2 using the MDRD equation
7. Known liver disease
8. Current haematological or solid organ malignancy including patients with less than 5 years of remission but excluding basal cell carcinoma
9. Pregnancy
10. Unwilling or unable to give informed consent.
11. Participation in another concurrent randomised clinical trial.
12. Life-expectancy less than 12 months.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
14/03/2014
Actual
5/12/2014
Date of last participant enrolment
Anticipated
Actual
17/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2028 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 7730 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 288645 0
Commercial sector/Industry
Name [1] 288645 0
AstraZeneca
Country [1] 288645 0
Australia
Primary sponsor type
Individual
Name
Professor Derek Chew
Address
Professor of Cardiology
Flinders University
Regional Director of Cardiology
Department of Cardiovascular Medicine
Southern Adelaide Local Health Network
Flinders Drive, Bedford Park
South Australia, 5042
Country
Australia
Secondary sponsor category [1] 287356 0
None
Name [1] 287356 0
Address [1] 287356 0
Country [1] 287356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290497 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290497 0
Research Ethics Office
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 290497 0
Australia
Date submitted for ethics approval [1] 290497 0
14/02/2014
Approval date [1] 290497 0
23/04/2014
Ethics approval number [1] 290497 0
88.14

Summary
Brief summary
Within a 1:1 randomised trial, this study will compare the effect of an antiplatelet approach with Ticagrelor versus placebo on 3, 6, and 12 month high-sensitivity troponin levels. It will also explore the frequency of late cardiovascular events, and the impact of P2Y12 platelet inhibition versus placebo on late cardiovascular events, among patients with elevations in high-sensitivity troponin not attributable to other acute clinical diagnoses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45962 0
Prof Derek Chew
Address 45962 0
Professor of Cardiology,
Flinders University,
Regional Director of Cardiology,
Department of Cardiovascular Medicine,
Southern Adelaide Local Health Network,
Flinders Drive, Bedford Park,
South Australia, 5042
Country 45962 0
Australia
Phone 45962 0
+618 8404 2001
Fax 45962 0
+618 8404 2150
Email 45962 0
[email protected]
Contact person for public queries
Name 45963 0
Ms Josette Wood
Address 45963 0
Cardiovascular Data Management,
South Australian Health and Medical Research Institute,
PO Box 11060,
Adelaide SA 5001
Country 45963 0
Australia
Phone 45963 0
+618 8128 4530
Fax 45963 0
Email 45963 0
[email protected]
Contact person for scientific queries
Name 45964 0
Prof Derek Chew
Address 45964 0
Professor of Cardiology,
Flinders University,
Regional Director of Cardiology,
Department of Cardiovascular Medicine,
Southern Adelaide Local Health Network,
Flinders Drive, Bedford Park,
South Australia, 5042
Country 45964 0
Australia
Phone 45964 0
+618 8404 2001
Fax 45964 0
+618 8404 2150
Email 45964 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
SourceTitleYear of PublicationDOI
EmbaseCost effectiveness of high-sensitivity troponin compared to conventional troponin among patients presenting with undifferentiated chest pain: A trial based analysis.2017https://dx.doi.org/10.1016/j.ijcard.2017.02.141
N.B. These documents automatically identified may not have been verified by the study sponsor.