A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
NCT ID: NCT00046228
Last Updated: 2014-07-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2461 participants
INTERVENTIONAL
2002-08-31
2008-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Comparing the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Combination With Two Different Heparin Regimens in Patients Undergoing Percutaneous Coronary Intervention.
NCT00269880
A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)
NCT02235389
CARESS in Acute Myocardial Infarction
NCT00220571
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
NCT00269893
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty
NCT02592694
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Abciximab; reteplase; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
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
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
abciximab; reteplase placebo; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
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
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
abciximab placebo; reteplase placebo, abciximab, abciximab
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
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
abciximab placebo; reteplase placebo, abciximab, abciximab
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
abciximab; reteplase placebo; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Abciximab; reteplase; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* patients who will not be undergoing a catherization within 4 hours of the qualifying Electrocardiogram
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Centocor, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Centocor, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Centocor, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Covina, California, United States
Modesto, California, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Weston, Florida, United States
Harvey, Illinois, United States
Rock Island, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Lewiston, Maine, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Pontiac, Michigan, United States
St Louis, Missouri, United States
Brooklyn, New York, United States
Flushing, New York, United States
Mineola, New York, United States
New York, New York, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Westlake, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Sayre, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Upland, Pennsylvania, United States
Wormleysburg, Pennsylvania, United States
York, Pennsylvania, United States
Pawtucket, Rhode Island, United States
Providence, Rhode Island, United States
Spartanburg, South Carolina, United States
Bristol, Tennessee, United States
Kingsport, Tennessee, United States
Amarillo, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Bremerton, Washington, United States
Marshfield, Wisconsin, United States
Waukesha, Wisconsin, United States
Adrogué, , Argentina
Buenos Aires, , Argentina
Corrientes, , Argentina
Merlo, , Argentina
Rosario, , Argentina
San Martín, , Argentina
Bruck an der Mur, , Austria
Deutschlandsberg, , Austria
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Antwerp, , Belgium
Bonheiden, , Belgium
Eeklo, , Belgium
Ghent, , Belgium
Herentals, , Belgium
Mechelen, , Belgium
Reet, , Belgium
Turnhout, , Belgium
Waregem, , Belgium
Westmalle, , Belgium
Dimitrovgrad, , Bulgaria
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Montreal, Quebec, Canada
Repentigny, Quebec, Canada
Benesov U Prahy, , Czechia
Bílovec, , Czechia
Boskovice, , Czechia
Brno, , Czechia
Bruntál, , Czechia
Čáslav, , Czechia
České Budějovice, , Czechia
Český Krumlov, , Czechia
Havíøov 1, , Czechia
Hodonín, , Czechia
Hradec Králové, , Czechia
Hranice, , Czechia
Jeseník, , Czechia
Jičín, , Czechia
Jihlava, , Czechia
Karniva-Ray N/A, , Czechia
Kyjov, , Czechia
Most, , Czechia
Nový Jičín, , Czechia
Odry, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Písek, , Czechia
Poruba, , Czechia
Prague, , Czechia
Praha 10 N/A, , Czechia
Prostějov, , Czechia
Přerov, , Czechia
Strakonice, , Czechia
Svitavy, , Czechia
Šumperk, , Czechia
Tábor, , Czechia
Teplice, , Czechia
Trutnov, , Czechia
Tøebíè 1, , Czechia
Tøinec 1, , Czechia
Ústí nad Labem, , Czechia
Ústí nad Orlicí, , Czechia
Valašské Meziříčí, , Czechia
Vyškov, , Czechia
Znojmo, , Czechia
Esbjerg, , Denmark
Frederikshavn, , Denmark
Hjÿrring N/A, , Denmark
Horsens, , Denmark
Kÿbenhavn Nv N/A, , Denmark
Kÿbenhavn Sud N/A, , Denmark
Kÿbenhavn Ÿ, , Denmark
Odense, , Denmark
Randers, , Denmark
Silkeborg, , Denmark
Viborg, , Denmark
Ÿlborg, , Denmark
Ÿrhus N, , Denmark
Besançon, , France
Colmar, , France
Metz, , France
Nancy, , France
Nancy Cedex N/A, , France
Nîmes, , France
Paris, , France
Vandœuvre-lès-Nancy, , France
Aachen, , Germany
Bad Nauheim, , Germany
Bad Segeberg, , Germany
Bremen, , Germany
Dresden, , Germany
Eschweiler, , Germany
Friedberg, , Germany
Fulda, , Germany
Hamburg, , Germany
Kaltenkirchen, , Germany
Magdeburg, , Germany
Mannheim, , Germany
Meißen, , Germany
München, , Germany
Münster, , Germany
Pfaffenhofen, , Germany
Radebeul, , Germany
Schönebeck, , Germany
Jerusalem, , Israel
Ramat Gan, , Israel
Leeuwarden, , Netherlands
Będzin, , Poland
Bielsko-Biala, , Poland
Bolesławiec, , Poland
Brzeg, , Poland
Częstochowa, , Poland
Gdansk, , Poland
Gdynia Poland, , Poland
Gliwice, , Poland
Gmina Końskie, , Poland
Gorlice, , Poland
Grójec, , Poland
Jastrzębie Zdrój, , Poland
Katowice, , Poland
Konin, , Poland
Kościerzyna, , Poland
Krakow, , Poland
Lodz, , Poland
Nowy Dwor M, , Poland
Nysa, , Poland
Opole, , Poland
Piotrkow Trybunalski, , Poland
Poznan, , Poland
Radomsko, , Poland
Ruda Śląska, , Poland
Skierniewice, , Poland
Swidnica, , Poland
Tychy, , Poland
Ustroń, , Poland
Warsaw, , Poland
Warszawa Poland, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Żyrardów, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Târgu Mureş, , Romania
Arcadia Pretoria N/A, , South Africa
Cape Town Western Province, , South Africa
Roodepoort Central Gauteng, , South Africa
Alicante, , Spain
Barcelona, , Spain
Madrid, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Gothenburg, , Sweden
Basel, , Switzerland
Bruderholz, , Switzerland
Liestal, , Switzerland
Antrim, , United Kingdom
Belfast, , United Kingdom
Brighton, , United Kingdom
Chichester, , United Kingdom
Durham, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Plymouth, , United Kingdom
Portadown, , United Kingdom
Saint Leonards-on-Sea, , United Kingdom
Southampton, , United Kingdom
Stockton-on-Tees, , United Kingdom
Worthing, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/j.ahj.2003.07.025.
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. doi: 10.1056/NEJMoa0706816.
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. doi: 10.1016/j.jcin.2009.11.012.
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. doi: 10.1016/j.jcin.2009.06.018.
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. doi: 10.1016/j.jcin.2009.07.009.
Related Links
Access external resources that provide additional context or updates about the study.
A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction - Finesse
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FINESSE
Identifier Type: -
Identifier Source: secondary_id
CR005410
Identifier Type: -
Identifier Source: secondary_id
CR005410
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.