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: January 21, 2014
Last verified: January 2014
Results First Received: March 26, 2009  
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
Condition: Myocardial Infarction
Interventions: Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
Drug: Abciximab; reteplase; abciximab placebo; abciximab
Drug: abciximab; reteplase placebo; abciximab placebo; abciximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted in 20 countries. The FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) study began enrollment in August 2002. It was planned that approximately 3,000 subjects would be enrolled. Because of enrollment difficulty, subject enrollment was stopped on 30 Dec 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2,461 subjects were enrolled in the study according to the sponsor’s clinical trial management system. Out of 2461 subjects, 2,452 subjects were randomly assigned to the 3 treatment groups.

Reporting Groups
  Description
Primary PCI Group Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
Abciximab Facilitated PCI Group Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
Reteplase/Abciximab Facilitated PCI Group Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Participant Flow for 2 periods

Period 1:   90 Days
    Primary PCI Group     Abciximab Facilitated PCI Group     Reteplase/Abciximab Facilitated PCI Group  
STARTED     806     818     828  
COMPLETED     793 [1]   810 [1]   813 [1]
NOT COMPLETED     13     8     15  
[1] The number completed includes subjects who died or were seen for a visit within specified window.

Period 2:   1 Year
    Primary PCI Group     Abciximab Facilitated PCI Group     Reteplase/Abciximab Facilitated PCI Group  
STARTED     806 [1]   818 [1]   828 [1]
COMPLETED     787 [2]   804 [2]   816 [3]
NOT COMPLETED     19     14     12  
[1] This is the number of participants that were originally randomized to the trial.
[2] The number completed includes subjects who died or were seen for a visit within specified window.
[3] The number completed includes subjects who died or were seen for a visit within specified window



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Primary PCI Group Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
Abciximab Facilitated PCI Group Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
Reteplase/Abciximab Facilitated PCI Group Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Total Total of all reporting groups

Baseline Measures
    Primary PCI Group     Abciximab Facilitated PCI Group     Reteplase/Abciximab Facilitated PCI Group     Total  
Number of Participants  
[units: participants]
  806     818     828     2452  
Age  
[units: years]
Mean ± Standard Deviation
  62.5  ± 11.4     61.9  ± 11.8     62.6  ± 11.4     62.4  ± 11.5  
Gender  
[units: participants]
       
Female     207     216     219     642  
Male     599     602     609     1810  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Composite of All-Cause Mortality or Complications of MI at 90 Days.   [ Time Frame: 90 days ]

2.  Secondary:   Complications of MI as Defined in the Primary Outcome Measure Through 90 Days   [ Time Frame: 90 Days ]

3.  Secondary:   All-Cause Mortality Through 90 Days   [ Time Frame: 90 days ]

4.  Secondary:   Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization   [ Time Frame: 60 to 90 minutes ]

5.  Secondary:   All-Cause Mortality Through 1 Year   [ Time Frame: 1 year ]

6.  Other Pre-specified:   Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7   [ Time Frame: Discharge/Day 7 ]

7.  Other Pre-specified:   Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7   [ Time Frame: Discharge/Day 7 ]

8.  Other Pre-specified:   Subjects With Severe Thrombocytopenia Through Discharge/Day 7   [ Time Frame: Discharge/Day 7 ]

9.  Other Pre-specified:   Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7   [ Time Frame: Discharge/Day 7 ]

10.  Other Pre-specified:   Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7   [ Time Frame: Discharge/Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Some AEs were collected separately per protocol and are reported as “Other Pre-Specified Outcomes Measures”.  


Results Point of Contact:  
Name/Title: Executive Director Clinical Research
Organization: Centocor Inc.
phone: 1-800-972-9063 ext 6171
e-mail: EBarnath@ITS.JNJ.COM


Publications of Results:
Publications automatically indexed to this study:


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: January 21, 2014
Health Authority: United States: Food and Drug Administration