Comparison of the effect of an anti-platelet intervention with Ticagrelor versus placebo on participants with asymptomatic elevations in troponin T

Comparison of the effect of an anti-platelet approach with Ticagrelor versus placebo on asymptomatic elevations in troponin T

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000189628

Enrollment

420

Registered

2014-02-21

Start date

2014-12-05

Completion date

2014-12-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

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.

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.

Outcome results