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Current Trials

Listed below are the trials currently being coordinated by GLCC.

• ACUITY
• APEX AMI
• CARISA - RANOLAZINE CVT 3034
• ExTRACT-TIMI 25

• MiG
• NZ HEART VALVE STUDY
• STICH
• ZEST

A randomised comparison of Angiomax^®   (bilvalirudin) versus heparin (enoxaparin or unfractionated heparin) in patients undergoing early invasive management for acute coronary syndromes without ST-segment elevation.  Randomisation is also designed to compare the timings of initiation of GPIIb/IIIa inhibitors in this population.  This phase III global study is expected to be conducted at 600 sites in North America, Europe and Australasia with a total 13,800 patients followed up for 1 year.  GLCC is currently coordinating 4 New Zealand sites in this trial with recruitment estimated to be completed in August 2005.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Monitoring.

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A Multicentre, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study of Pexelizumab in Patients with Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Sample size 8,500.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Monitoring.

Combination Assessment of Ranolazine In Stable Angina. An open-label, long-term, safety study of Ranolazine SR for chronic stable angina pectoris at doses of 500mg, 750mg and 1000mg twice a day administered in combination with background anti-anginal therapy. Sample Size 600 patients.

GLCC Activities: Regulatory Submission

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ExTRACT-TIMI 25

Enoxiparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment. A randomised, double-blind, double-dummy, parallel group, multinational, clinical study to evaluate the efficacy and safety of enoxaparin versus unfractionated heparin in patients with acute ST-segment elevation myocardial infarction receiving fibrinolytic therapy. Sample size 21,000.

GLCC Activities: Regulatory Submission

Gestational Diabetes; treatment with metformin compared with insulin. Sample size is 750 subjects to be recruited from centres in Australia and New Zealand. The trial is expected to be completed in 2-3 years.

GLCC Activities: National Regulatory Submissions, Site Management, Monitoring, Data Collection, Data Management, Statistical Analysis.

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To determine whether natriuretic peptides are a reliable and clinically useful non-invasive marker of severity, progression, and left ventricular remodelling in aortic valve disease. 3 year follow-up. Sample size 400 patients.

GLCC Activities: National Project Management, Data Processing, Data Management, Statistical Analysis.

GLCC Activities: Project Management, Regulatory Submissions, Site Management, Monitoring.

New Zealand Eplerenone Aortic Stenosis Trial. A randomised double-blinded placebo controlled trial to investigate the effects of long-term treatment with the aldosterone receptor antagonist eplerenone on the left ventricular mass and volume with magnetic resonance imaging in patients with asymptomatic moderate to severe aortic stenosis. Sample size: 66 patients. Timeframe: 36 months.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Monitoring, Randomisation, Data Processing, Data Management, Statistical Analysis.