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Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) Clinical research trials and Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE). Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) clinical trial. Subjects frequently obtain the most expert healthcare possible for their Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE) Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE)
Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE)
For Condition: Acute coronary syndrome
Status: Recruiting
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Rest angina lasting at least 10 minutes that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray, occurring within 24 hours of randomization; - TIMI risk score greater than or equal to 4 (a qualitative test for CK-MB or Troponin may be utilized for screening purposes; however, a quantitative test must still be performed.) EXCLUSION CRITERIA - Increased bleeding risk as defined by any of the following: * Ischemic stroke within the last year * Any previous hemorrhagic stroke, intracranial tumor, or intracranial aneurysm * Recent (<1 month) trauma or major surgery (including bypass surgery) * Active bleeding (other than minor skin abrasions) - Impaired hemostasis including any one of the following: * Known International Normalized Ratio (INR) >1.5 * Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders) * Known or history of thrombocytopenia (platelet count <100,000/mL) * History of thrombocytopenia with glycoprotein IIb/IIIa inhibitor therapy, heparin, or enoxaparin - Angina from a secondary cause such as: * severe, uncontrolled hypertension (systolic blood pressure >180 mm Hg despite treatment) * anemia * valvular disease * congenital heart disease * hypertrophic cardiomyopathy * restrictive or constrictive cardiomyopathy * thyrotoxicosis. - Bundle branch block not known to be old in the context of angina. - Undergone a percutaneous coronary intervention (PCI) within the past 24 hours. - A known allergy to heparin, low molecular weight heparin, pork or pork products. - Any contraindications to treatment with UFH or LMWH. - A recent (<48 hours) or planned spinal/epidural anesthesia or puncture. - Thrombolytic therapy within the preceding 24 hours. - Any other clinically relevant serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min], rendering implementation of the protocol or interpretation of the study results difficult. - Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or has previously enrolled in this trial. - Inability to comply with the protocol (e.g., has uncooperative attitude, inability to return for follow-up visits). - Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent. - A prosthetic heart valve
Total Enrollment:
Location and Contact Information:
Aventis Pharmaceuticals Inc. *Recruiting*
Bridgewater, New Jersey, 08807-0977
United States
Recruiting William Byra 908-243-7501
Additional Information:
Study ID Numbers: XRP4563B/4001;
Study Start Date: June 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077818
Other Acute Coronary Syndrome Studies:
1. Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE)
Related Studies:
Other Acute coronary syndrome Clinical Trials
Other New Jersey Clinical Trials
Other Bridgewater Clinical Trials
Enoxaparin versus Unfractionated Heparin in Subjects Who Present to the Emergency Department with Acute Coronary Syndrome (RESCUE)
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