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Home > "A" Clinical Trials Conditions > A safety, efficacy trial evaluating the early administration of abciximab and reteplase combination treatment in PCI  A safety, efficacy trial evaluating the early administration of abciximab and reteplase combination treatment in PCI
A safety, efficacy trial evaluating the early administration of abciximab and reteplase combination treatment in PCI
For Condition: Myocardial Infarction
Status: Recruiting
Sponsor(s): Centocor ,
Synopsis: The purpose of this medical research study is to determine whether the administration of abciximab and reteplase before patients have a coronary intervention, is safe and effective in the treatment of acute myocardial infarction compared to only abciximab given during coronary intervention.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Be at least 21 years of age - Have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 hours of randomization, and one of the following: a. ST-segment elevation greater than or equal to 2 mm in 2 (minimum of 4 mm total in all leads) or more contiguous precordial ECG leads (anterior infarction) b. ST-segment depression greater than or equal to 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead (AVF), and V6 (true posterior infarction) c. ST-segment elevation greater than or equal to 1 mm in 2 or more contiguous limb ECG leads (other infarction) d. New or presumably new left bundle branch block (LBBB) Exclusion Criteria: - Low risk clinical presentation, specifically have the combination of age < 60 years and local inferior infarction (ST-segment elevation in only leads II, III, or AVF) - Patients in whom the investigator anticipates that diagnostic angiography will occur within 60 minutes of qualifying ECG - Patients in whom the investigator anticipates that PCI cannot occur within 4 hours of the qualifying ECG - Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (eg, arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease or hypotension) - Planned use of bivalirudin or other direct thrombin inhibitor during PCI - Use of a fibrinolytic agent within 14 days prior to randomization - Use of abciximab or any other GP IIb/IIIa inhibitor within 30 days prior to randomization - Use of LMWH within 24 hours prior to randomization - PCI within 7 days prior to randomization - Suspected active internal bleeding or history of hemorrhagic diathesis - Major surgery, biopsy of a parenchymal organ, eye surgery, or serious trauma within 6 weeks prior to randomization - Gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance within 6 weeks prior to randomization - History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the previous 2 years or any CVA with a residual neurological deficit - Administration of oral anticoagulants within 7 days prior to randomization unless prothrombin time (PT) less than or equal to 1.2 times control (or international normalized ratio [INR] less than or equal to 1.4), or ongoing treatment with oral anticoagulants - Known current platelet count less than 100,000 cells/uL - Intracranial neoplasm, arteriovenous malformation, aneurysm, or aneurysm repair - Confirmed hypertension with any repeated and reliable measurement of systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg at any time from presentation at the hospital to randomization - Presumed or documented history of vasculitis - Puncture of a non-compressible vessel within 24 hours prior to randomization - Known allergy to abciximab or other murine proteins - Known allergy to aspirin - History of heparin allergy or heparin-induced thrombocytopenia or heparin-induced thrombosis - Coexistent condition associated with a limited life expectancy (eg, advanced cancer) - Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization - History or symptoms of aortic dissection - Prolonged (greater than 20 minutes) or traumatic cardiopulmonary resuscitation (CPR) within 2 weeks prior to randomization - Weight > 120 kg - Known positive pregnancy test for women of childbearing age - Patients receiving any UFH within 6 hours prior to randomization unless confirmation of an aPTT less than or equal to 70 seconds is obtained prior to randomization
Total Enrollment: 3000
Location and Contact Information:
Cleveland Clinic Cardiovascular Coordinating Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Clinical Information Line 877-736-5805
Additional Information:
Study ID Numbers: C0116T40; FINESSE
Study Start Date: September 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046228
Other Myocardial Infarction Studies:
1. Multi-Ethnic Study of Atherosclerosis (MESA)
2. A safety, efficacy trial evaluating the early administration of abciximab and reteplase combination treatment in PCI
3. Vascular Interaction with Age in Myocardial Infarction
4. Look AHEAD: Action for Health in Diabetes
5. Women's Antioxidant and Cardiovascular Study (WACS)
Related Studies:
Other Myocardial Infarction Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
A safety, efficacy trial evaluating the early administration of abciximab and reteplase combination treatment in PCI
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