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

Professor Derek Chew0 个研究点目标入组 420 人开始时间: 2014年2月21日最近更新: 2020年1月13日

试验速览

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•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.

•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.

发起方

Professor Derek Chew