Skip to main content
OpenTrials
Completed

NCT Number: NCT00046228

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adrogué, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abciximab placebo; reteplase placebo, abciximab, abciximab

Drug

placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

Abciximab; reteplase; abciximab placebo; abciximab

Drug

0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

abciximab; reteplase placebo; abciximab placebo; abciximab

Drug

0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. All-Cause Mortality Through 90 Days

    Time frame: 90 days

    All cause mortality occurred through 90 days from randomization.

  3. Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization

    Time frame: 60 to 90 minutes

  4. All-Cause Mortality Through 1 Year

    Time frame: 1 year

    All-cause mortality through 1 year from randomization.

Other outcomes

  1. 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).

  2. 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.

  3. Subjects With Severe Thrombocytopenia Through Discharge/Day 7

    Time frame: Discharge/Day 7

    Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.

  4. Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7

    Time frame: Discharge/Day 7

  5. 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.

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 25, 2002
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.