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Sponsors and Collaborators: |
Canadian Heart Research Centre Sanofi-Aventis |
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Information provided by: | Canadian Heart Research Centre |
ClinicalTrials.gov Identifier: | NCT00518245 |
The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective in the treatment of patients presenting to the emergency room with chest pain and no electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical features
Condition | Intervention | Phase |
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Unstable Angina |
Drug: enoxaparin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Open Label, Randomized, Parallel-Group Investigation to Evaluate the Efficacy and Safety of Enoxaparin Versus no Enoxaparin in Subjects With Chest Pain Syndrome and no ECG or Biomarker Abnormalities |
Enrollment: | 11 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: enoxaparin
Enoxaparin will be given subcutanteously at a dose of 1mg/kg every 12 hours for a minimum of 48 hours (4 doses) and a maximum of 8 days until a diagnostic / therapeutic procedure is performed, or at the discretion of the investigator.
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2: No Intervention |
Patients with chest pain and abnormal electrocardiogram or bloodwork (biomarker) indicative of a heart attack benefit from anticoagulant therapy such as enoxaparin. However, even patients without abnormalities on the electrocardiogram or bloodwork are at increased risk for heart attack or death, if they have certain clinical risk factors. It is currently not known whether enoxaparin is also beneficial for these patients.
Comparison: enoxaparin in addition to optimal standard care at the discretion of the treating physician, versus optimal standard care without enoxaparin
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 |
Study Chair: | Shaun Goodman, MD, MSc | Canadian Heart Research Centre |
Principal Investigator: | David Fitchett, MD | St. Michael's Hospital, Toronto |
Study Director: | Anatoly Langer, MD, MSc | Canadian Heart Research Centre |
Principal Investigator: | Andrew T Yan, MD | Canadian Heart Research Centre |
Responsible Party: | Canadian Heart Research Centre ( Dr. Shaun Goodman, Co-Chair, CHRC ) |
Study ID Numbers: | CHRC-022 |
Study First Received: | August 16, 2007 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00518245 |
Health Authority: | Canada: Health Canada |
unstable angina drug therapy myocardial ischemia myocardial infarction hemorrhage |
Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Ischemia Hemorrhage |
Enoxaparin Chest Pain Signs and Symptoms Congenital Abnormalities Infarction Myocardial Infarction Angina, Unstable |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |