Clinical Trials Group
In recent years this Group has been led by Professor Robert Wilcox, with input from a variety of academic and NHS colleagues. The following describes the general directions that have been followed and records the main trials that have been undertaken.
The need for the controlled evaluation of a new treatment (such as beta blockers in acute myocardial infarction) or a new strategy (such as reducing the duration of hospital stay after infarction) has always been appreciated and reflected in the design of the studies undertaken by this Group.
The Group has been engaged in nearly every major thrombolytic trial either as the lead clinical and statistical centre (ASSET, LATE, INJECT and IN-TIME 2) or as the UK or European co-ordinating centre (GISSI-2/International, GUSTO-1, COBALT, GUSTO-III, GUSTO-IV and AMI).
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HERO-2 - a comparison of bivalirudin with heparin in patients treated with streptokinase.
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PURSUIT assessed the intravenous GPIIb/IIIa inhibitor in patients with acute ischaemic syndromes and shared a modest benefit at 30 days.
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OPUS - TIMI 16 assessed the oral GPIIb/IIIa inhibitor as long term therapy in patients with acute ischaemic coronary syndromes and confirmed the long term potential risk of such treatments.
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GUSTO IV ACS assessed abciximal in patients with ACS for whom an interventional treatment was not mandated and, surprisingly, shared no benefit irrespective of patient demographics.
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The RITA studies - the group has contributed to these randomised trials of intervention versus conservative management in patients with unstable angina.
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EPHESUS - the role of the spironalactone derivitive eplerenone in post infarct heart failure.
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UKPACE - single and dual chamber pacing in elderly patients with complete heart block.
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REPLACE 2 - bivalirudin with provisional glycoprotein IIb/IIIa inhibition compared with routine glycoprotein IIb/IIIa inhibition with heparin with PCI.
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EXTRACT - a comparison of enoxaparin with unfractionated heparin in patients with ST elevation acute MI
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CLARITY - the addition of clopidogrel to aspirin and fibrinolytic therapy in patients with acute myocardial infarction.
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TRITON - a comparison of prasugrel versus clopidogrel in patients with acute coronary syndromes proceeding to PCI.
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MERLIN - an assessment of ranolazine in patients with acute myocardial infarction.
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ACUITY - bivalirudin with provisional glycoprotein IIb/IIIa inhibitor vs scheduled glycoprotein IIb/IIIa inhibitor plus heparin in patients with ACS.
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ATLAS - a phase 2 assessment of an anti 10a compound Rivaroxaban in acute coronary syndromes.
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CLASSICS - clopidogrel in coronary stenting.
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REACT- rescue therapies in 'failed' thrombolysis.
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PROACTIVE - pioglatazone in diabetic vascular disease.
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IRIS - an assessment of a conducting tissue IF channel inhibitor in stable angina.
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BBC1 - a randomised comparison of simple versus complex drug eluting stenting for bifurcation lesions.
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TRA 2P - a platelet thrombin receptor antagonist in acute coronary syndromes.
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MRC – ILA - an interleukin 1 receptor antagonist in NSTEMI.
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REDEEM - a phase 2 study of an oral direct thrombin inhibitor in acute coronary syndromes.
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STREAM - pre-hospital thrombolysis versus primary PCI for STEMI.
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TRILOGY - prasugrel versus clopidogrel in patients with acute coronary syndromes scheduled for medical therapy.
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PLATO - a phase III comparison of an oral direct platelet PTY12 receptor blocker versus clopidogrel in acute coronary syndromes.
In collaboration with the Thrombosis and Haemostasis Research Group led by Dr Sue Fox, the Clinical Trials Group has also been involved in the assessment of several agents designed to reduce platelet function as an approach to anti-thrombotic therapy. These have included studies on new aspirin preparations and novel platelet membrane receptor inhibitors in patients admitted with unstable angina. There have also been collaborations with pharmaceutical companies in assessment of new anti-thrombins in large phase II trials.