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

Myocardial Infarction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046228
• Other study ID #: CR005410
• Secondary ID: FINESSECR005410
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2002
• Last updated: July 25, 2014
• Start date: August 2002
• Est. completion date: January 2008

Study information

• Verified date: July 2014
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2461
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centocor, Inc.	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Israel,  Netherlands,  Poland,  Romania,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

Ellis SG, Armstrong P, Betriu A, Brodie B, Herrmann H, Montalescot G, Neumann FJ, Smith JJ, Topol E; Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events Investigators. Facilitated percutaneous coronary intervention versus primary percu — View Citation

Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neum — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7	All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).	Discharge/Day 7	Yes
Other	Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through 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.	Discharge/Day 7	Yes
Other	Subjects With Severe Thrombocytopenia Through Discharge/Day 7	Severe thrombocytopenia is defined as platelet count < 50,000 cells/µL.	Discharge/Day 7	Yes
Other	Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7		Discharge/Day 7	Yes
Other	Subjects With Pre-Specified Complications of Index Myocardial Infarction Through 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.	Discharge/Day 7	Yes
Primary	The Composite of All-Cause Mortality or Complications of MI at 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).	90 days	Yes
Secondary	Complications of MI as Defined in the Primary Outcome Measure Through 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.	90 Days	Yes
Secondary	All-Cause Mortality Through 90 Days	All cause mortality occurred through 90 days from randomization.	90 days	Yes
Secondary	Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization		60 to 90 minutes	Yes
Secondary	All-Cause Mortality Through 1 Year	All-cause mortality through 1 year from randomization.	1 year	Yes

External Links

•   A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction - Finesse