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.

Condition	Treatment or Intervention	Phase
Myocardial Infarction	Drug: abciximab  Drug: reteplase	Phase III

Further Study Details: 

Expected Total Enrollment:  3000

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

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

Clinical Trial Information Line      1-877-736-5805 

Ohio
      Cleveland Clinic Cardiovascular Coordinating Center, Cleveland,  Ohio,  44195,  United States; Recruiting

Study ID Numbers:  C0116T40; FINESSE
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  September 24, 2002
ClinicalTrials.gov Identifier:  NCT00046228
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08