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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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 ]
    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).


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 ]
    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.


Other Outcome Measures:
  • 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.


Enrollment: 2461
Study Start Date: August 2002
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ¿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 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; 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 235 Study Locations
Sponsors and Collaborators
Centocor, Inc.
Eli Lilly and Company
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00046228     History of Changes
Other Study ID Numbers: CR005410, FINESSE, CR005410
Study First Received: September 24, 2002
Results First Received: March 26, 2009
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Myocardial infarction
percutaneous coronary intervention
abciximab
reteplase
safety and efficacy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Reteplase
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014