Clinical trial NCT00046228: A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
percutaneous coronary intervention
abciximab
reteplase
safety and efficacy
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2002-09-25
Enrollment: 2461
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Composite of All-Cause Mortality or Complications of MI at 90 Days.
timeFrame: 90 days
Secondary outcomes:
measure: Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
timeFrame: 90 Days
measure: All-Cause Mortality Through 90 Days
timeFrame: 90 days
measure: Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
timeFrame: 60 to 90 minutes
measure: All-Cause Mortality Through 1 Year
timeFrame: 1 year
Other outcomes:
measure: Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7
timeFrame: Discharge/Day 7
measure: Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7
timeFrame: Discharge/Day 7
measure: Subjects With Severe Thrombocytopenia Through Discharge/Day 7
timeFrame: Discharge/Day 7
measure: Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7
timeFrame: Discharge/Day 7
measure: Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7
timeFrame: Discharge/Day 7
Locations:
city: Phoenix
country: United States
state: Arizona
city: Covina
country: United States
state: California
city: Modesto
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Harvey
country: United States
state: Illinois
city: Rock Island
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
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state: Louisiana
city: Lewiston
country: United States
state: Maine
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Pontiac
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
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state: Ohio
city: Dayton
country: United States
state: Ohio
city: Westlake
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
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state: Pennsylvania
city: Wormleysburg
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state: Pennsylvania
city: York
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state: Pennsylvania
city: Pawtucket
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state: Rhode Island
city: Providence
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state: Rhode Island
city: Spartanburg
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state: South Carolina
city: Bristol
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state: Tennessee
city: Kingsport
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state: Texas
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state: Washington
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state: Wisconsin
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state: Wisconsin
city: Adrogue
country: Argentina
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country: Argentina
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city: Linz
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city: Wien
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city: Gent
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city: Dimitrovgrad
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country: Canada
state: Alberta
city: Montreal
country: Canada
state: Quebec
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country: Canada
state: Quebec
city: Benesov U Prahy
country: Czech Republic
city: Bilovec N/A
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city: Boskovice
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city: Brno
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city: Bruntál 1
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city: Caslav N/A
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city: Ceske Budejovice
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city: Hradec Kralove
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city: Jicin N/A
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city: Tøebíè 1
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city: Usti Nad Orlici N/A
country: Czech Republic
city: Valasske Mezirici N/A
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city: Vyskov N/A
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city: Ústí Nad Labem 11
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country: Denmark
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country: Denmark
city: Hjÿrring N/A
country: Denmark
city: Horsens N/A
country: Denmark
city: Kÿbenhavn Nv N/A
country: Denmark
city: Kÿbenhavn Sud N/A
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country: Germany
city: Bad Nauheim
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city: Jerusalem
country: Israel
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country: Israel
city: Leeuwarden
country: Netherlands
city: Bedzin
country: Poland
city: Bielsko-Biala
country: Poland
city: Boleslawiec
country: Poland
city: Brzeg
country: Poland
city: Czestochowa
country: Poland
city: Gdansk N/A
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city: Gdynia Poland
country: Poland
city: Gliwice N/A
country: Poland
city: Gorlice
country: Poland
city: Grojec
country: Poland
city: Jastrzebie-Zdroj
country: Poland
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country: Poland
city: Katowice
country: Poland
city: Konin N/A
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city: Konskie N/A
country: Poland
city: Koscierzyna
country: Poland
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country: Poland
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country: Poland
city: Nowy Dwor M
country: Poland
city: Nysa N/A
country: Poland
city: Opole N/A
country: Poland
city: Piotrkow Trybunalski
country: Poland
city: Poznan N/A
country: Poland
city: Radomsko
country: Poland
city: Ruda Slaska
country: Poland
city: Skierniewice
country: Poland
city: Swidnica
country: Poland
city: Tychy N/A
country: Poland
city: Ustron N/A
country: Poland
city: Warszawa N/A
country: Poland
city: Warszawa Poland
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zabrze N/A
country: Poland
city: Zyrardow N/A
country: Poland
city: Bucuresti
country: Romania
city: Cluj Napoca
country: Romania
city: Iasi
country: Romania
city: Targu Mures
country: Romania
city: Arcadia Pretoria N/A
country: South Africa
city: Cape Town Western Province
country: South Africa
city: Roodepoort Central Gauteng
country: South Africa
city: Alicante N/A
country: Spain
city: Barcelona N/A
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santander N/A
country: Spain
city: Santander
country: Spain
city: Santiago De Compostela N/A
country: Spain
city: Santiago De Compostela
country: Spain
city: Göteborg N/A
country: Sweden
city: Göteborg
country: Sweden
city: Basel N/A
country: Switzerland
city: Bruderholz N/A
country: Switzerland
city: Liestal
country: Switzerland
city: Antrim
country: United Kingdom
city: Belfast
country: United Kingdom
city: Brighton
country: United Kingdom
city: Chichester
country: United Kingdom
city: Durham
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough N/A
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Portadown
country: United Kingdom
city: Southampton
country: United Kingdom
city: St Leonards On Sea
country: United Kingdom
city: Stockton On Tees
country: United Kingdom
city: Worthing
country: United Kingdom
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.