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

July 25, 2014 updated by: Centocor, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2461

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Adrogue, Argentina
      • Buenos Aires, Argentina
      • Corrientes, Argentina
      • Merlo, Argentina
      • Rosario, Argentina
      • San Martin, Argentina
  • Austria
      • Bruck An Der Mur, Austria
      • Deutschlandsberg, Austria
      • Innsbruck, Austria
      • Linz, Austria
      • Wien, Austria
  • Belgium
      • Antwerpen, Belgium
      • Bonheiden, Belgium
      • Eeklo, Belgium
      • Gent, Belgium
      • Herentals, Belgium
      • Mechelen, Belgium
      • Reet, Belgium
      • Turnhout, Belgium
      • Waregem, Belgium
      • Westmalle, Belgium
  • Bulgaria
      • Dimitrovgrad, Bulgaria
      • Haskovo, Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Repentigny, Quebec, Canada
  • Czech Republic
      • Benesov U Prahy, Czech Republic
      • Bilovec N/A, Czech Republic
      • Boskovice, Czech Republic
      • Brno, Czech Republic
      • Bruntál, Czech Republic
      • Bruntál 1, Czech Republic
      • Caslav N/A, Czech Republic
      • Ceske Budejovice, Czech Republic
      • Cesky Krumlov N/A, Czech Republic
      • Havíøov 1, Czech Republic
      • Hodonín 1, Czech Republic
      • Hradec Kralove, Czech Republic
      • Hranice 1, Czech Republic
      • Jeseník 1, Czech Republic
      • Jicin N/A, Czech Republic
      • Jihlava N/A, Czech Republic
      • Karniva-Ray N/A, Czech Republic
      • Kyjov, Czech Republic
      • Most N/A, Czech Republic
      • Novy Jicin N/A, Czech Republic
      • Odry, Czech Republic
      • Olomouc, Czech Republic
      • Ostrava, Czech Republic
      • Pisek N/A, Czech Republic
      • Poruba, Czech Republic
      • Praha 10 N/A, Czech Republic
      • Praha 9, Czech Republic
      • Prerov N/A, Czech Republic
      • Prostejov N/A, Czech Republic
      • Strakonice N/A, Czech Republic
      • Sumperk N/A, Czech Republic
      • Svitavy N/A, Czech Republic
      • Tabor N/A, Czech Republic
      • Teplice, Czech Republic
      • Trutnov N/A, Czech Republic
      • Tøebíè 1, Czech Republic
      • Tøinec 1, Czech Republic
      • Usti Nad Orlici N/A, Czech Republic
      • Valasske Mezirici N/A, Czech Republic
      • Vyskov N/A, Czech Republic
      • Znojmo N/A, Czech Republic
      • Ústí Nad Labem 11, Czech Republic
  • Denmark
      • Esbjerg N/A, Denmark
      • Frederikshavn N/A, Denmark
      • Hjÿrring N/A, Denmark
      • Horsens N/A, Denmark
      • Kÿbenhavn Nv N/A, Denmark
      • Kÿbenhavn Sud N/A, Denmark
      • Kÿbenhavn Ÿ, Denmark
      • Odense N/A, Denmark
      • Randers, Denmark
      • Silkeborg, Denmark
      • Viborg N/A, Denmark
      • Ÿlborg, Denmark
      • Ÿrhus N, Denmark
  • France
      • Besancon Cedex, France
      • Colmar N/A, France
      • Metz, France
      • Nancy Cedex, France
      • Nancy Cedex N/A, France
      • Nimes, France
      • Paris, France
      • Vandoeuvre Les Nancy Cedex, France
  • Germany
      • 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
  • Israel
      • Jerusalem, Israel
      • Ramat-Gan, Israel
  • Netherlands
      • Leeuwarden, Netherlands
  • Poland
      • Bedzin, Poland
      • Bielsko-Biala, Poland
      • Boleslawiec, Poland
      • Brzeg, Poland
      • Czestochowa, Poland
      • Gdansk N/A, Poland
      • Gdynia Poland, Poland
      • Gliwice N/A, Poland
      • Gorlice, Poland
      • Grojec, Poland
      • Jastrzebie-Zdroj, Poland
      • Katowice, Poland
      • Katowice N/A, Poland
      • Konin N/A, Poland
      • Konskie N/A, Poland
      • Koscierzyna, Poland
      • Krakow N/A, Poland
      • Lodz N/A, Poland
      • Nowy Dwor M, Poland
      • Nysa N/A, Poland
      • Opole N/A, Poland
      • Piotrkow Trybunalski, Poland
      • Poznan N/A, Poland
      • Radomsko, Poland
      • Ruda Slaska, Poland
      • Skierniewice, Poland
      • Swidnica, Poland
      • Tychy N/A, Poland
      • Ustron N/A, Poland
      • Warszawa, Poland
      • Warszawa N/A, Poland
      • Warszawa Poland, Poland
      • Wroclaw, Poland
      • Zabrze N/A, Poland
      • Zyrardow N/A, Poland
  • Romania
      • Bucuresti, Romania
      • Cluj Napoca, Romania
      • Iasi, Romania
      • Targu Mures, Romania
  • South Africa
      • Arcadia Pretoria N/A, South Africa
      • Cape Town Western Province, South Africa
      • Roodepoort Central Gauteng, South Africa
  • Spain
      • Alicante N/A, Spain
      • Barcelona, Spain
      • Barcelona N/A, Spain
      • Madrid, Spain
      • Santander, Spain
      • Santander N/A, Spain
      • Santiago De Compostela, Spain
      • Santiago De Compostela N/A, Spain
  • Sweden
      • Göteborg, Sweden
      • Göteborg N/A, Sweden
  • Switzerland
      • Basel N/A, Switzerland
      • Bruderholz N/A, Switzerland
      • Liestal, Switzerland
  • United Kingdom
      • 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 N/A, United Kingdom
      • Plymouth, United Kingdom
      • Portadown, United Kingdom
      • Southampton, United Kingdom
      • St Leonards On Sea, United Kingdom
      • Stockton On Tees, United Kingdom
      • Worthing, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Covina, California, United States
      • Modesto, California, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Saint Petersburg, Florida, United States
      • St Petersburg, Florida, United States
      • Tallahassee, Florida, United States
      • Weston, Florida, United States
    • Illinois
      • Harvey, Illinois, United States
      • Rock Island, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maine
      • Lewiston, Maine, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Pontiac, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New York
      • Brooklyn, New York, United States
      • Flushing, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Dayton, Ohio, United States
      • Westlake, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • 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
    • Rhode Island
      • Pawtucket, Rhode Island, United States
      • Providence, Rhode Island, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Kingsport, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Galveston, Texas, United States
      • Houston, Texas, United States
      • Lubbock, Texas, United States
    • Washington
      • Bremerton, Washington, United States
    • Wisconsin
      • Marshfield, Wisconsin, United States
      • Waukesha, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Drug: 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
Drug: 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
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
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
Drug: 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
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; 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
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
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 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Composite of All-Cause Mortality or Complications of MI at 90 Days.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
Time Frame: 90 Days
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.
90 Days
All-Cause Mortality Through 90 Days
Time Frame: 90 days
All cause mortality occurred through 90 days from randomization.
90 days
Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
Time Frame: 60 to 90 minutes
60 to 90 minutes
All-Cause Mortality Through 1 Year
Time Frame: 1 year
All-cause mortality through 1 year from randomization.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7
Time Frame: Discharge/Day 7
All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).
Discharge/Day 7
Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7
Time Frame: Discharge/Day 7
Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.
Discharge/Day 7
Subjects With Severe Thrombocytopenia Through Discharge/Day 7
Time Frame: Discharge/Day 7
Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.
Discharge/Day 7
Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7
Time Frame: Discharge/Day 7
Discharge/Day 7
Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7
Time Frame: Discharge/Day 7
Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.
Discharge/Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centocor, Inc.

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

September 24, 2002

First Submitted That Met QC Criteria

September 24, 2002

First Posted (ESTIMATE)

September 25, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005410
  • FINESSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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