A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)

• Complications of MI as Defined in the Primary Outcome Measure Through 90 Days [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
  The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.
• All-Cause Mortality Through 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  All cause mortality occurred through 90 days from randomization.
• Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization [ Time Frame: 60 to 90 minutes ] [ Designated as safety issue: Yes ]
• All-Cause Mortality Through 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  All-cause mortality through 1 year from randomization.

The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.

The purpose of this medical research study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention. This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death, and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment.

Patients will receive either abciximab and reteplease or abciximab alone. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.

• Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
  0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
• Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
  placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
• Drug: Abciximab; reteplase; abciximab placebo; abciximab
  0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

• Experimental: 001
  Abciximab; reteplase; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
  Intervention: Drug: Abciximab; reteplase; abciximab placebo; abciximab
• Experimental: 002
  abciximab; reteplase placebo; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
  Intervention: Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
• Experimental: 003
  abciximab placebo; reteplase placebo, abciximab, abciximab placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
  Intervention: Drug: abciximab placebo; reteplase placebo, abciximab, abciximab

• Ellis SG, Armstrong P, Betriu A, Brodie B, Herrmann H, Montalescot G, Neumann FJ, Smith JJ, Topol E; Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events Investigators. Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial. Am Heart J. 2004 Apr;147(4):E16.
• Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17.
• Montalescot G, Ellis SG, de Belder MA, Janssens L, Katz O, Pluta W, Ecollan P, Tendera M, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Armstrong P, Brodie BR, Herrmann HC, Neumann FJ, Effron MB, Lu J, Barnathan ES, Topol EJ; Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events Investigators. Enoxaparin in primary and facilitated percutaneous coronary intervention A formal prospective nonrandomized substudy of the FINESSE trial (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events). JACC Cardiovasc Interv. 2010 Feb;3(2):203-12.
• Herrmann HC, Lu J, Brodie BR, Armstrong PW, Montalescot G, Betriu A, Neuman FJ, Effron MB, Barnathan ES, Topol EJ, Ellis SG; FINESSE Investigators. Benefit of facilitated percutaneous coronary intervention in high-risk ST-segment elevation myocardial infarction patients presenting to nonpercutaneous coronary intervention hospitals. JACC Cardiovasc Interv. 2009 Oct;2(10):917-24.
• Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Hamankiewicz M, Pluta W, Oldroyd K, Ecollan P, Janssens L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. 1-year survival in a randomized trial of facilitated reperfusion: results from the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. JACC Cardiovasc Interv. 2009 Oct;2(10):909-16.

Inclusion Criteria:

• Patients who have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of A heart attack not eliminated with nitrates and onset within 6 hours of randomization,and confirmation by Electrocardiogram

Exclusion Criteria:

• Low risk clinical presentation
• patients who will not be undergoing a catherization within 4 hours of the qualifying Electrocardiogram