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.
Official Title
Safety and efficacy trial evaluating fondaparinux use in a broad range of patients with ST segment elevation acute MI
Conditions
– Myocardial Infarction
Study Type
Interventional
Study Design
Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Study Start
Eligibility & Criteria
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: BothCriteriaInclusion 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 consentExclusion 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
Total Enrolment
10000
Contact Details
[1] Heart Research Institute – Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting, Peter Thompson, M.D., Principal Investigator[2] OrganonAll content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.
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