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.
2 other identifiers
interventional
2,461
19 countries
227
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2002
Longer than P75 for phase_3
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 24, 2002
CompletedFirst Posted
Study publicly available on registry
September 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
May 15, 2009
CompletedJuly 31, 2014
July 1, 2014
5.4 years
September 24, 2002
March 26, 2009
July 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Composite of All-Cause Mortality or Complications of MI at 90 Days.
Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization).
90 days
Secondary Outcomes (4)
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
90 Days
All-Cause Mortality Through 90 Days
90 days
Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
60 to 90 minutes
All-Cause Mortality Through 1 Year
1 year
Other Outcomes (5)
Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7
Discharge/Day 7
Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7
Discharge/Day 7
Subjects With Severe Thrombocytopenia Through Discharge/Day 7
Discharge/Day 7
- +2 more other outcomes
Study Arms (3)
001
EXPERIMENTALAbciximab; 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
002
EXPERIMENTALabciximab; 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
003
EXPERIMENTALabciximab 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
Interventions
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Low risk clinical presentation
- patients who will not be undergoing a catherization within 4 hours of the qualifying Electrocardiogram
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
- Eli Lilly and Companycollaborator
Study Sites (227)
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Phoenix, Arizona, United States
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Covina, California, United States
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Modesto, California, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Weston, Florida, United States
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Harvey, Illinois, United States
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Rock Island, Illinois, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Lewiston, Maine, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Pontiac, Michigan, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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Flushing, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Westlake, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Wormleysburg, Pennsylvania, United States
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York, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Providence, Rhode Island, United States
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Spartanburg, South Carolina, United States
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Bristol, Tennessee, United States
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Kingsport, Tennessee, United States
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Amarillo, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Bremerton, Washington, United States
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Marshfield, Wisconsin, United States
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Waukesha, Wisconsin, United States
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Adrogué, Argentina
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Buenos Aires, Argentina
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Corrientes, Argentina
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Merlo, Argentina
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Rosario, Argentina
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San Martín, Argentina
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Bruck an der Mur, Austria
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Deutschlandsberg, Austria
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Innsbruck, Austria
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Linz, Austria
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Vienna, Austria
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Antwerp, Belgium
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Bonheiden, Belgium
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Eeklo, Belgium
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Ghent, Belgium
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Herentals, Belgium
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Mechelen, Belgium
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Reet, Belgium
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Turnhout, Belgium
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Waregem, Belgium
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Westmalle, Belgium
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Dimitrovgrad, Bulgaria
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Haskovo, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Montreal, Quebec, Canada
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Repentigny, Quebec, Canada
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Benesov U Prahy, Czechia
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Bílovec, Czechia
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Boskovice, Czechia
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Brno, Czechia
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Bruntál, Czechia
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Čáslav, Czechia
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České Budějovice, Czechia
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Český Krumlov, Czechia
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Havíøov 1, Czechia
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Hodonín, Czechia
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Hradec Králové, Czechia
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Hranice, Czechia
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Jeseník, Czechia
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Jičín, Czechia
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Jihlava, Czechia
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Karniva-Ray N/A, Czechia
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Kyjov, Czechia
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Most, Czechia
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Nový Jičín, Czechia
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Odry, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Písek, Czechia
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Poruba, Czechia
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Prague, Czechia
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Praha 10 N/A, Czechia
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Prostějov, Czechia
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Přerov, Czechia
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Strakonice, Czechia
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Svitavy, Czechia
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Šumperk, Czechia
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Tábor, Czechia
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Teplice, Czechia
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Trutnov, Czechia
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Tøebíè 1, Czechia
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Tøinec 1, Czechia
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Ústí nad Labem, Czechia
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Ústí nad Orlicí, Czechia
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Valašské Meziříčí, Czechia
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Vyškov, Czechia
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Znojmo, Czechia
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Esbjerg, Denmark
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Frederikshavn, Denmark
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Hjÿrring N/A, Denmark
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Horsens, Denmark
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Kÿbenhavn Nv N/A, Denmark
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Kÿbenhavn Sud N/A, Denmark
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Kÿbenhavn Ÿ, Denmark
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Odense, Denmark
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Randers, Denmark
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Silkeborg, Denmark
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Viborg, Denmark
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Ÿlborg, Denmark
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Ÿrhus N, Denmark
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Besançon, France
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Colmar, France
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Metz, France
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Nancy, France
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Nancy Cedex N/A, France
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Nîmes, France
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Paris, France
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Vandœuvre-lès-Nancy, France
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Aachen, Germany
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Bad Nauheim, Germany
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Bad Segeberg, Germany
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Bremen, Germany
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Dresden, Germany
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Eschweiler, Germany
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Friedberg, Germany
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Fulda, Germany
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Hamburg, Germany
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Kaltenkirchen, Germany
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Magdeburg, Germany
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Mannheim, Germany
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Meißen, Germany
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München, Germany
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Münster, Germany
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Pfaffenhofen, Germany
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Radebeul, Germany
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Schönebeck, Germany
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Jerusalem, Israel
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Ramat Gan, Israel
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Leeuwarden, Netherlands
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Będzin, Poland
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Bielsko-Biala, Poland
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Bolesławiec, Poland
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Brzeg, Poland
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Częstochowa, Poland
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Gdansk, Poland
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Gdynia Poland, Poland
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Gliwice, Poland
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Gmina Końskie, Poland
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Gorlice, Poland
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Grójec, Poland
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Jastrzębie Zdrój, Poland
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Katowice, Poland
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Konin, Poland
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Kościerzyna, Poland
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Krakow, Poland
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Lodz, Poland
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Nowy Dwor M, Poland
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Nysa, Poland
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Opole, Poland
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Piotrkow Trybunalski, Poland
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Poznan, Poland
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Radomsko, Poland
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Ruda Śląska, Poland
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Skierniewice, Poland
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Swidnica, Poland
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Tychy, Poland
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Ustroń, Poland
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Warsaw, Poland
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Warszawa Poland, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Żyrardów, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Târgu Mureş, Romania
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Arcadia Pretoria N/A, South Africa
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Cape Town Western Province, South Africa
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Roodepoort Central Gauteng, South Africa
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Alicante, Spain
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Barcelona, Spain
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Madrid, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Gothenburg, Sweden
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Basel, Switzerland
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Bruderholz, Switzerland
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Liestal, Switzerland
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Antrim, United Kingdom
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Belfast, United Kingdom
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Brighton, United Kingdom
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Chichester, United Kingdom
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Durham, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Plymouth, United Kingdom
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Portadown, United Kingdom
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Saint Leonards-on-Sea, United Kingdom
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Southampton, United Kingdom
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Stockton-on-Tees, United Kingdom
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Worthing, United Kingdom
Related Publications (5)
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.
PMID: 15077099RESULTEllis 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.
PMID: 18499565RESULTMontalescot 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.
PMID: 20170878DERIVEDHerrmann 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.
PMID: 19850249DERIVEDEllis 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.
PMID: 19850248DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Some AEs were collected separately per protocol and are reported as "Other Pre-Specified Outcomes Measures".
Results Point of Contact
- Title
- Executive Director Clinical Research
- Organization
- Centocor Inc.
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2002
First Posted
September 25, 2002
Study Start
August 1, 2002
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
July 31, 2014
Results First Posted
May 15, 2009
Record last verified: 2014-07