| September 24, 2002 |
| June 26, 2009 |
| August 2002 |
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| The Composite of All-Cause Mortality or Complications of MI at 90 Days. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] |
| The composite of all-cause mortality or complications of MI (rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricularfibrillation occurring > 48 hours after randomization) at 90 days |
| Complete list of historical versions of study NCT00046228 on ClinicalTrials.gov Archive Site |
- Complications of MI as Defined in the Primary Outcome Measure Through 90 Days [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
- All-Cause Mortality Through 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- 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 ]
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- Complications of MI as defined in the primary endpoint through 90 days
- All-cause mortality through 90 days
- Percent of subjects with ST-segment resolution > 70% from baseline at 60 to 90 minutes following randomization Incidence of nonintracranial TIMI bleeding (either major or minor) through discharge/day 7
- Intracranial hemorrhage (including hemorrhagic transformation) through discharge/day 7
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| A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse) |
| A Muticenter, Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction. |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Myocardial Infarction |
- Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
- Drug: Abciximab; reteplase; abciximab placebo; abciximab
- Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
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- 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.
- 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.
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| Completed |
| 2452 |
| January 2008 |
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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
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| Both |
| 21 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00046228 |
| Executive Director Clinical Research, Centocor, Inc. |
| CR005410, CR005410, FINESSE |
| Centocor, Inc. |
- PDL BioPharma, Inc.
- Eli Lilly and Company
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| Study Director: |
Centocor, Inc. Clinical Trial |
Centocor, Inc. |
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| Centocor, Inc. |
| June 2009 |