A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
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ClinicalTrials.gov Identifier: NCT00046228 |
Recruitment Status
:
Completed
First Posted
: September 25, 2002
Results First Posted
: May 15, 2009
Last Update Posted
: July 31, 2014
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Condition or disease | Intervention/treatment | 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 |
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 (Clinical Trial) |
Actual Enrollment : | 2461 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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. |
Study Start Date : | August 2002 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

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 ¿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
|
- 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).
- 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.
- All-Cause Mortality Through 90 Days [ Time Frame: 90 days ]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 ]
- All-Cause Mortality Through 1 Year [ Time Frame: 1 year ]All-cause mortality through 1 year from randomization.
- 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).
- 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.
- Subjects With Severe Thrombocytopenia Through Discharge/Day 7 [ Time Frame: Discharge/Day 7 ]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 ]
- 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.

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046228

Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Additional Information:
Publications of Results:
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 |
First Posted: | September 25, 2002 Key Record Dates |
Results First Posted: | May 15, 2009 |
Last Update Posted: | July 31, 2014 |
Last Verified: | July 2014 |
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 Antibodies, Monoclonal |
Immunoglobulin Fab Fragments Reteplase Tissue Plasminogen Activator Anticoagulants Platelet Aggregation Inhibitors Immunologic Factors Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |