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

Sponsors and Collaborators:	Centocor, Inc. PDL BioPharma, Inc. Eli Lilly and Company
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00046228

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: abciximab placebo; reteplase placebo, abciximab, abciximab Drug: Abciximab; reteplase; abciximab placebo; abciximab Drug: abciximab; reteplase placebo; abciximab placebo; abciximab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Reteplase Abciximab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

The Composite of All-Cause Mortality or Complications of MI at 90 Days. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	2452
Study Start Date:	August 2002
Study Completion Date:	January 2008

Arms	Assigned Interventions
001: Experimental	Drug: Abciximab; reteplase; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
002: Experimental	Drug: abciximab; reteplase placebo; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
003: Experimental	Drug: abciximab placebo; reteplase placebo, abciximab, abciximab placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h

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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046228

Sponsors and Collaborators

Centocor, Inc.

PDL BioPharma, Inc.

Eli Lilly and Company

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction - Finesse This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Centocor, Inc. ( Executive Director Clinical Research )
Study ID Numbers:	CR005410, CR005410, FINESSE
Study First Received:	September 24, 2002
Results First Received:	March 26, 2009
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00046228 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

percutaneous coronary intervention
reteplase
abciximab
safety and efficacy
Myocardial infarction

Study placed in the following topic categories:

Anticoagulants
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Abciximab
Fibrinolytic Agents
Ischemia

Cardiovascular Agents
Necrosis
Fibrin Modulating Agents
Reteplase
Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Anticoagulants
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Abciximab
Fibrinolytic Agents
Cardiovascular Agents
Ischemia

Pharmacologic Actions
Necrosis
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Reteplase
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on July 02, 2009