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

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

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: Blood Thinners Heart Attack

Drug Information available for: Insulin ORG 31540 Fondaparinux sodium Heparin

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:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	July 8, 2003
Last Updated:	September 12, 2006
ClinicalTrials.gov Identifier:	NCT00064428 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Acute Myocardial Infarction

Study placed in the following topic categories:

Heart Diseases
Anticoagulants
Myocardial Ischemia
Vascular Diseases
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Ischemia

Org 31540
Insulin
Calcium heparin
Fibrin Modulating Agents
Necrosis
Infarction
Myocardial Infarction
Heparin

Additional relevant MeSH terms:

Heart Diseases
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Ischemia

Pharmacologic Actions
Org 31540
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009