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

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: fondaparinux sodium Drug: heparin Drug: Glucose-insulin-potassium (GIK)	Phase III

MedlinePlus related topics:

Heart Attack

ChemIDplus related topics:

Insulin Fondaparinux sodium ORG 31540 Heparin Dextrose Potassium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Safety and Efficacy Trial Evaluating Fondaparinux Use in a Broad Range of Patients With ST Segment Elevation Acute MI

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:	12000
Study Start Date:	August 2003

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064428

Show 384 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

More Information

Publications of Results:

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.

Publications indexed to this study:

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.

Study ID Numbers:	EFC5112, SR90107
First Received:	July 8, 2003
Last Updated:	September 12, 2006
ClinicalTrials.gov Identifier:	NCT00064428
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Acute Myocardial Infarction

Study placed in the following topic categories:

Necrosis

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Fondaparinux

Ischemia

Infarction

Heparin

Myocardial Infarction

Insulin

Org 31540

Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00064428