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A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
This study has been completed.
Study NCT00046228   Information provided by Centocor, Inc.
First Received: September 24, 2002   Last Updated: June 26, 2009   History of Changes

September 24, 2002
June 26, 2009
August 2002
 
The Composite of All-Cause Mortality or Complications of MI at 90 Days. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
The composite of all-cause mortality or complications of MI (rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricularfibrillation occurring > 48 hours after randomization) at 90 days
Complete list of historical versions of study NCT00046228 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Complications of MI as defined in the primary endpoint through 90 days
  • All-cause mortality through 90 days
  • Percent of subjects with ST-segment resolution > 70% from baseline at 60 to 90 minutes following randomization Incidence of nonintracranial TIMI bleeding (either major or minor) through discharge/day 7
  • Intracranial hemorrhage (including hemorrhagic transformation) through discharge/day 7
 
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.

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Myocardial Infarction
  • Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
  • Drug: Abciximab; reteplase; abciximab placebo; abciximab
  • Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
2452
January 2008
 

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00046228
Executive Director Clinical Research, Centocor, Inc.
CR005410, CR005410, FINESSE
Centocor, Inc.
  • PDL BioPharma, Inc.
  • Eli Lilly and Company
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP