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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00046228
First received: September 24, 2002
Last updated: July 25, 2014
Last verified: July 2014

September 24, 2002
July 25, 2014
August 2002
January 2008   (final data collection date for primary outcome measure)
The Composite of All-Cause Mortality or Complications of MI at 90 Days. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
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).
Not Provided
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 ]
    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.
  • All-Cause Mortality Through 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    All cause mortality occurred through 90 days from randomization.
  • 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 ]
    All-cause mortality through 1 year from randomization.
Not Provided
  • Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 [ Time Frame: Discharge/Day 7 ] [ Designated as safety issue: Yes ]
    All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).
  • Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 [ Time Frame: Discharge/Day 7 ] [ Designated as safety issue: Yes ]
    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.
  • Subjects With Severe Thrombocytopenia Through Discharge/Day 7 [ Time Frame: Discharge/Day 7 ] [ Designated as safety issue: Yes ]
    Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.
  • Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 [ Time Frame: Discharge/Day 7 ] [ Designated as safety issue: Yes ]
  • Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 [ Time Frame: Discharge/Day 7 ] [ Designated as safety issue: Yes ]
    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.
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • 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; 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 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 ¿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: 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
    Interventions:
    • Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
    • Drug: Abciximab; reteplase; abciximab placebo; abciximab
  • 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
    Interventions:
    • Drug: Abciximab; reteplase; abciximab placebo; abciximab
    • Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
  • 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
    Interventions:
    • Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
    • Drug: abciximab placebo; reteplase placebo, abciximab, abciximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2461
January 2008
January 2008   (final data collection date for primary outcome measure)

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
United States,   Argentina,   Austria,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Israel,   Netherlands,   Poland,   Romania,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00046228
CR005410, FINESSE, CR005410
Not Provided
Centocor, Inc.
Centocor, Inc.
Eli Lilly and Company
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
July 2014

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