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Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes Clinical research trials and Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes. Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes clinical trial. Test subjects typically obtain the finest healthcare available for their Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes
Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes
For Condition: Myocardial Ischemia,Unstable Angina,Myocardial Infarction
Status: Recruiting
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria All patients must meet the following criteria: - Male or nonpregnant female greater than or equal to 18 years old - Ischemic pain originating or persisting at rest, or its clinical equivalent, lasting greater than or equal to 10 minutes and occurring within the 24 hours before enrollment - At least 2 of the following: * ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (greater than or equal to 1 mm), or transient (<30 minutes) ST-segment elevation greater than or equal to 0.1 mV (greater than or equal to 1 mm) in at least 2 contiguous leads * Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin I or T greater than the established criteria at each site OR creatine kinase CK-MB level greater than the site's upper limit of normal * Age greater than or equal to 60 years Exclusion Criteria A patient, meeting the above inclusion criteria, will be excluded for any of the following: - Known or suspected pregnancy - Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding - Impaired hemostasis: 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), thrombocytopenia (platelet count <100,000/mL), or history of thrombocytopenia with GP 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 - PCI within the past 24 hours, not including coronary angiography only - Allergy to pork or pork products - Contraindications to UFH or LMWH - Recent (<48 hours) or planned spinal/epidural anesthesia or puncture - Thrombolytic therapy within the preceding 24 hours - Other serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min - Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial - Inability to give informed consent or high likelihood of being unavailable for follow-up - Not a candidate for intervention, (angiography or PCI) - Treatment with a direct thrombin inhibitor or a low molecular weight heparin other than enoxaparin in the 7 days preceding enrollment.
Total Enrollment: 8000
Location and Contact Information:
Duke Clinical Research Institute *Recruiting*
Durham, North Carolina, 07969
United States
Recruiting Lisa Berdan 919-668-8707
Additional Information:
Study ID Numbers: ENP.GMA.301;
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043784
Other Unstable Angina Studies:
1. Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes
2. ARISE - Aggressive Reduction of Inflammation Stops Events
Related Studies:
Other Unstable Angina Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Open Study of enoxaparin vs. unfractionated heparin in patients with acute coronary syndromes
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