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• CARISA - Ranolazine CVT 3033
• COBALT
• EPHESUS
• EXPEDITION
• HERO-2
• GISSI 2
• GUSTO I
• GUSTO IIa
• GUSTO IIb
• GUSTO III

• GUSTO IV
• ISIS-2
• ISIS-3
• ISIS-4
• PARAGON A
• PARAGON B
• SYMPHONY
• 2^nd SYMPHONY
• VALIANT

CARISSA - Ranolanzine CVT 3033

Combination Assessment of Ranolazine In Stable Angina. A double-blind, randomized, stratified, placebo-controlled, parallel study of Ranolazine SR at doses of 750mg twice a day and 1000mg twice a day in combination with other anti-anginal medications in 648 patients with Chronic stable angina pectoris.

GLCC Activities: Regulatory Submissions. Trial results yet to be published.

COBALT

The Continuous Infusion versus Double-Bolus Administration of Alteplase (COBALT) Investigators. A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. 398 hospitals participated with a total enrollment of 7,169 patients.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Data Processing.

EPHESUS Trial

Eplerenone In Heart Failure Post Acute Myocardial Infarction. Double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of eplerenone in patients with heart failure following acute myocardial infarction. Sample Size 6,200 patients

GLCC Activities: National Regulatory Submissions

EXPEDITION

Na+/H+ Excahnge Inhibition to Prevent Coronary Events in Acute Cardiac Conditions. A double-blind, placebo controlled, multinational trial to investigate the effect of IV treatment with the Na+/H+ exchange inhibitor cariporide (HOE642) on all-cause mortality and non-fatal myocardial infarction in patients at risk of myocardial necrosis during and after coronary artery bypass graft (CABG) surgery.

GLCC Activities: National Regulatory Submissions

Hirulog Early Reperfusion/Occlusion. An open prospectively randomized comparison of Hirulog versus Heparin in patients receiving Aspirin and thrombolysis (Streptokinase) for the treatment of acute myocardial infarction. 17,091 patients at 539 sites in 47 countries. Trial results yet to be published.

GLCC Activities:
Global: Project Management, Monitoring, Monitoring Database Management
Regional: Project Management, Regulatory Submissions, Site Management, Monitoring, Data Processing
National: Project Management, Regulatory Submissions, Site Management, Monitoring, Data Processing

GISSI 2

Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI). GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, National Randomisation, Data Processing

GUSTO I

The Global Use of Strategies to Open Occluded Coronary Arteries. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction in 15 countries and 1,081 hospitals, enrolling 41,021 patients.

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

GUSTO IIa

The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIa Investigators. Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. At 275 participating hospitals in 12 countries, with enrollment of 2,564 patients.

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

GUSTO IIb

The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb Investigators. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes. 373 hospitals in 13 countries enrolled 12,142 patients.

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

GUSTO III

The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators. A comparison of reteplase with alteplase for acute myocardial infarction. A total of 15,059 patients from 807 hospitals in 20 countries.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Monitoring, National Randomisation, Data Processing, Drug Distribution Coordination.

GUSTO IV

The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO IV) Investigators. A trial evaluating the efficacy and safety of ReoPro™, given as a bolus followed by a 24- or 48- hour infusion, for the treatment of Acute Coronary Syndrome without ST-segment elevation. Trial results yet to be published.

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

ISIS-2

ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction in 417 hospitals.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Data Processing.

ISIS-3

ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. A randomised comparison of streptokinase vs. tissue plasminogen activator vs. anistreplase and of aspirin plus heparin vs. aspirin alone among 41,299 cases of suspected acute myocardial infarction.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Data Processing.

ISIS-4

ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group. A randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients entering 1086 hospitals with suspected acute myocardial infarction.

GLCC Activities: National Project Management, Regulatory Submissions, Site Management, Data Processing.

PARAGON A

Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organisation Network. An international, randomized, controlled trial of lamifiban (a platelet glycoprotein IIb/IIIa inhibitor), heparin, or both in unstable angina. 273 hospitals in 20 countries randomised 2,282 patients.

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

The PARAGON-B Investigators. Randomized, placebo-controlled trial of titrated intravenous lamifiban for acute coronary syndromes. 5,225 patients enrolled at 389 centers in 29 countries.

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

Sibrafiban Versus Aspirin to Yield Maximum Protection From Ischemic Heart Events Post-Acute Coronary Syndromes. Comparison of sibrafiban with aspirin for prevention of cardiovascular events after acute coronary syndromes: a randomised trial of 9,233 patients.

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

Sibrafiban Versus Aspirin to Yield Maximum Protection From Ischemic Heart Events Post-Acute Coronary Syndromes. Randomized trial of aspirin, sibrafiban, or both for secondary prevention after acute coronary syndromes in 6,671 patients.

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

Valsartan In Acute myocardial infarction. Multinational, multicenter, double-blind, randomized, active controlled, parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril and their combination in high-risk patients after myocardial infarction. Sample Size 14,500.

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