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

This study has been completed.

Study NCT00046228 Information provided by Centocor, Inc.

First Received: September 24, 2002 Last Updated: June 26, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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
A total of 2,452 subjects from 20 countries were randomized in this study. 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
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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: 90 Days

	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
STARTED	806	818	828
COMPLETED	793^[1]	810^[2]	813^[3]
NOT COMPLETED	13	8	15

[1]	The number completed includes subjects who died or were seen for a visit within specified window.
[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.

Period: 1 Year

	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
STARTED	806^[1]	818^[2]	828^[3]
COMPLETED	787^[4]	804^[5]	816^[6]
NOT COMPLETED	19	14	12

[1]	This is the number of participants that were originally randomized to the trial.
[2]	This is the number of participants that were originally randomized to the trial.
[3]	This is the number of participants that were originally randomized to the trial.
[4]	The number completed includes subjects who died or were seen for a visit within specified window.
[5]	The number completed includes subjects who died or were seen for a visit within specified window.
[6]	The number completed includes subjects who died or were seen for a visit within specified window

Baseline Characteristics

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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

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

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1. Primary:

The Composite of All-Cause Mortality or Complications of MI at 90 Days. [ 90 days ]

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2. Secondary:

Complications of MI as Defined in the Primary Outcome Measure Through 90 Days [ 90 Days ]

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3. Secondary:

All-Cause Mortality Through 90 Days [ 90 days ]

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4. Secondary:

Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization [ 60 to 90 minutes ]

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5. Secondary:

All-Cause Mortality Through 1 Year [ 1 year ]

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6. Other Pre-specified:

Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 [ Discharge/Day 7 ]

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7. Other Pre-specified:

Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 [ Discharge/Day 7 ]

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8. Other Pre-specified:

Subjects With Severe Thrombocytopenia Through Discharge/Day 7 [ Discharge/Day 7 ]

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9. Other Pre-specified:

Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 [ Discharge/Day 7 ]

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10. Other Pre-specified:

Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 [ Discharge/Day 7 ]

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