ACTRN12614000189628
Terminated
Not Applicable
Comparison of the effect of an anti-platelet approach with Ticagrelor versus placebo on asymptomatic elevations in troponin T
Professor Derek Chew0 sites420 target enrollmentFebruary 21, 2014
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Professor Derek Chew
- Enrollment
- 420
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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