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

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

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
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

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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Measure Type	Primary
Measure Title	The Composite of All-Cause Mortality or Complications of MI at 90 Days.
Measure Description	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).
Time Frame	90 days
Safety Issue	Yes

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.
Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.

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

Measured Values

	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Number of Participants Analyzed [units: participants]	806	818	828
The Composite of All-Cause Mortality or Complications of MI at 90 Days. [units: participants]	86	86	81

Statistical Analysis 1 for The Composite of All-Cause Mortality or Complications of MI at 90 Days.

Groups ^[1]	Primary PCI Group vs. Reteplase/Abciximab Facilitated PCI Group
Method ^[2]	Log Rank
P Value ^[3]	0.551
Hazard Ratio (HR) ^[4]	0.91
95% Confidence Interval	( 0.67 to 1.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death & resuscitated v fib assessed by the investigator)
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for The Composite of All-Cause Mortality or Complications of MI at 90 Days.

Groups ^[1]	Primary PCI Group vs. Abciximab Facilitated PCI Group
Method ^[2]	Log Rank
P Value ^[3]	0.858
Hazard Ratio (HR) ^[4]	0.97
95% Confidence Interval	( 0.72 to 1.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for The Composite of All-Cause Mortality or Complications of MI at 90 Days.

Groups ^[1]	Abciximab Facilitated PCI Group vs. Reteplase/Abciximab Facilitated PCI Group
Method ^[2]	Log Rank
P Value ^[3]	0.676
Hazard Ratio (HR) ^[4]	0.94
95% Confidence Interval	( 0.69 to 1.27 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

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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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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:

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 percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial. Am Heart J. 2004 Apr;147(4):E16.

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, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17.

Publications automatically indexed to this study:

Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Hamankiewicz M, Pluta W, Oldroyd K, Ecollan P, Janssens L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. 1-year survival in a randomized trial of facilitated reperfusion: results from the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. JACC Cardiovasc Interv. 2009 Oct;2(10):909-16.

Responsible Party:	Centocor, Inc. ( Executive Director Clinical Research )
Study ID Numbers:	CR005410, CR005410, FINESSE
Study First Received:	September 24, 2002
Results First Received:	March 26, 2009
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00046228 History of Changes
Health Authority:	United States: Food and Drug Administration