MICHELANGELO OASIS-6 : FOndaparinux in ST Elevation Myocardial Infarction - Tabular View

Tracking Information
First Received Date ^ICMJE	July 8, 2003
Last Updated Date	September 12, 2006
Start Date ^ICMJE	August 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00064428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	MICHELANGELO OASIS-6 : FOndaparinux in ST Elevation Myocardial Infarction
Official Title ^ICMJE	Safety and Efficacy Trial Evaluating Fondaparinux Use in a Broad Range of Patients With ST Segment Elevation Acute MI
Brief Summary	The purpose of this research study is to determine the efficacy and safety of fondaparinux (Arixtra) in preventing death and repeat heart attacks and their complications.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myocardial Infarction
Intervention ^ICMJE	Drug: fondaparinux sodium Drug: heparin Drug: Glucose-insulin-potassium (GIK)
Study Arms / Comparison Groups
Publications *	Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA; OASIS-6 Trial Group. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006 Apr 5;295(13):1519-30. Epub 2006 Mar 14. Díaz R, Goyal A, Mehta SR, Afzal R, Xavier D, Pais P, Chrolavicius S, Zhu J, Kazmi K, Liu L, Budaj A, Zubaid M, Avezum A, Ruda M, Yusuf S. Glucose-insulin-potassium therapy in patients with ST-segment elevation myocardial infarction. JAMA. 2007 Nov 28;298(20):2399-405.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12000
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients presenting or admitted to hospital with: a) signs and symptoms of acute myocardial infarction (AMI) b) able to randomize within 24 hours from symptom onset, and c) definite ECG changes indicating STEMI: persistant ST-elevation (greater than or equal to 0.2 mV in two contiguous precordial leads, or greater than or equal to 0.1 mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI written informed consent Exclusion criteria: age < 21 years currently receiving an oral anticoagulant agent with an INR > 1.8 any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding hemorrhagic stroke within the last 12 months indication for anticoagulation other than acute coronary syndrome (ACS) pregnant women or women of child-bearing potential who are not using an effective method of contraception co-morbid condition with a life expectancy < 6 months prior enrolment in one of the fondaparinux ACS trials participation in another pharmacotherapeutic study within the prior 30 days or currently receiving an experitmental pharmacological agent known allergy to heparin or fondaparinux
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00064428
Responsible Party
Study ID Numbers ^ICMJE	EFC5112, SR90107
Study Sponsor ^ICMJE	Sanofi-Aventis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sanofi-Aventis
Verification Date	September 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP