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PLATO TRIAL |
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|---|---|
| Problem | ACS |
| Format | Double-blinded multi-center RCT |
| Treatment | Ticagrelor |
| Control | Clopidogrel |
| Population | 18624 ACS +-STEMI, 24hrs after symptoms |
| Inclusion criteria | Patients were eligible for enrollment if they were hospitalized for an acute coronary syndrome, with or without ST-segment elevation, with an onset of symptoms during the previous 24 hours. For patients who had an acute coronary syndrome without ST-segment elevation, at least two of the following three criteria had to be met: ST-segment changes on electrocardiography, indicating ischemia; a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors (age ≥60 years; previous myocardial infarction or coronary-artery bypass grafting [CABG]; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease; or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body-surface area). For patients who had an acute coronary syndrome with ST-segment elevation, the following two inclusion criteria had to be met: persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block, and the intention to perform primary PCI. |
| Exclusion criteria | Major exclusion criteria were any contraindication against the use of clopidogrel, fibrinolytic therapy within 24 hours before randomization, a need for oral anticoagulation therapy, an increased risk of bradycardia, and concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer. |
| Follow-up | 12 months |
| Primary endpoint | Composite of death from vascular causes, MI or stroke |
| Secondary endpoint(s) | The principal secondary efficacy end point was the primary efficacy variable studied in the subgroup of patients for whom invasive management was planned at randomization. Additional secondary end points (analyzed for the entire study population) were the composite of death from any cause, myocardial infarction, or stroke; the composite of death from vascular causes, myocardial infarction, stroke, severe recurrent cardiac ischemia, recurrent cardiac ischemia, transient ischemic attack, or other arterial thrombotic events; myocardial infarction alone; death from cardiovascular causes alone; stroke alone; and death from any cause. |
| Details | . |
| Brief summary: | Ticagrelor superior to clopidogrel in ACS, including mortality |
| PAPER: Ticagrelor versus clopidogrel in patients with acute coronary syndromes. | |
|---|---|
| Date | 10 Sep 2009 |
| Journal | N Engl J Med. 2009 Sep 10;361(11):1045-57. Epub 2009 Aug 30. |
| Information | Ticagrelor (vs Clopidogrel) -Significant reduction in composite of death from vascular causes, MI or stroke -No difference in overall major bleeding -Increased rate of non-procedure-related bleeding |
| PAPER: Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. | |
|---|---|
| Date | 23 Jan 2010 |
| Journal | Lancet. 2010 Jan 23;375(9711):283-93. Epub 2010 Jan 13. |
| Information | Sub-group analysis of patients undergoing invasive strategy -Significant reduction in composite of death from vascular causes, MI or stroke -No difference in total major or severe bleeding |