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

• Conditions: Asymptomatic elevated troponin; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12614000189628
• Lead Sponsor: Professor Derek Chew

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the change in troponin T level compared with baseline as measured by the Roche Elecsys high-sensitivity troponin assay.[6 months after randomisation.]

Secondary Outcome Measures

Name	Time	Method
Change in troponin T level compared with baseline as measured by the Roche high-sensitivity troponin assay.[3 months after randomisation.];Safety outcomes including significant bleeding using BARC primarily, plus GUSTO, TIMI and ACUITY definitions.[3, 6, and 12 months after randomisation.];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.[Up to 12 months after randomisation.]