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Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) Clinical research trials and Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25). Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) clinical trial. Human subjects often receive the most effective healthcare possible for their Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25) condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)  Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
For Condition: Myocardial Infarction,Acute ST-segment elevation
Status: Recruiting
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Patients with ST-segment elevation acute myocardial infarction meeting all of the following criteria: - Male or non-pregnant female greater than or equal to 18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years) - Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization - ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in two (2) or more contiguous precordial leads, or left bundle-branch block - Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase - Written informed consent will be obtained EXCLUSION CRITERIA Cardiovascular - Evidence of cardiogenic shock at randomization - Acute pericarditis - History or symptoms suggestive of aortic dissection - MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine Hemorrhagic Risk - Any minor head trauma or any other trauma occurring after the index acute myocardial infarction - Active or recent (< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria. - Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia - Any single reliable recording of systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg prior to randomization - Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease - Any known structural damage or other pathologic process involving the central nervous system - Any head trauma within 6 months prior to randomization - Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization - Traumatic or prolonged cardiopulmonary resuscitation (> 2 minutes) within 2 weeks prior to randomization - Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization - Acute peptic ulcer disease within 3 months prior to randomization Prior or Concomitant Pharmacologic Therapy - Administration of abciximab (ReoProä), within the previous 7 days or eptifibatide (Integrilinä), or tirofiban (Aggrastatä) within the previous 24 hours prior to randomization - Current therapy with oral anticoagulants, or an International Normalized Ratio of >1.5 - Administration of a low molecular weight heparin within 8 hours prior to randomization. - Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products - Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase) General - Known platelet count <100,000 cells/microL or history of heparin-induced thrombocytopenia - Known clinically significant anemia (Hemoglobin <10 g/dL which is < 6.2 mmol/L) - Known renal insufficiency with serum creatinine >220 mmol/L (2.5 mg/dL) for men and >175 mmol/L (2.0 mg/dL) for women when assessed prior to baseline examination. - Advanced neoplastic or other life-threatening disease with a life expectancy of <12 months - Pregnancy or parturition within the last 90 days or currently breast feeding - Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test. - Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25 - History of drug or alcohol abuse - Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study - Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and who are unlikely to complete the study
Total Enrollment: 21000
Location and Contact Information:
Aventis Pharmaceuticals Inc *Recruiting*
Bridgewater, New Jersey, 08807-0890
United States
Recruiting Frank Jiang 908-304-6470
Additional Information:
Study ID Numbers: XRP4563B/3001;
Study Start Date: December 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077792
Other Myocardial Infarction Studies:
1. Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
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Other Myocardial Infarction Clinical Trials
Other New Jersey Clinical Trials
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Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
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