A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)

This study has been completed.

Study NCT00059215 Information provided by Eli Lilly and Company

First Received on April 21, 2003. Last Updated on May 21, 2010 History of Changes

Results First Received: April 19, 2010

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
Conditions:	Cardiovascular Diseases Heart Diseases
Interventions:	Drug: Prasugrel (CS-747) Drug: Clopidogrel

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
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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
Prasugrel (CS-747) 40-mg LD/7.5 mg MD	Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60-mg LD/10-mg MD	Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60-mg LD/15-mg MD	Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
Clopidogrel	Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

Participant Flow: Overall Study

	Prasugrel (CS-747) 40-mg LD/7.5 mg MD	Prasugrel (CS-747) 60-mg LD/10-mg MD	Prasugrel (CS-747) 60-mg LD/15-mg MD	Clopidogrel
STARTED	200	200	251	254
COMPLETED	187 ^[1]	186	236	239
NOT COMPLETED	13	14	15	15
Adverse Event	5	5	9	9
Death	0	0	3	0
Lost to Follow-up	1	2	0	0
Withdrawal by Subject	4	4	1	3
Protocol Violation	1	0	1	0
Protocol entry criteria not met	1	1	0	2
Physician Decision	1	2	1	1

[1]	One subject discontinued before receiving treatment and is not included in the evaluable set.

Baseline Characteristics

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Reporting Groups

	Description
Prasugrel (CS-747) 40 mg LD/7.5 mg MD	Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60 mg LD/10 mg MD	Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60-mg LD/15-mg MD	Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
Clopidogrel	Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day

Baseline Measures

	Prasugrel (CS-747) 40 mg LD/7.5 mg MD	Prasugrel (CS-747) 60 mg LD/10 mg MD	Prasugrel (CS-747) 60-mg LD/15-mg MD	Clopidogrel	Total
Number of Participants [units: participants]	199	200	251	254	904
Age, Customized [units: participants]
<=18 years	0	0	0	0	0
>18 and <= 65 years	129	152	185	195	661
> 65 years	70	48	66	59	243
Age [units: years] Mean ± Standard Deviation	60.4 ± 8.72	58.7 ± 9.15	59.4 ± 8.97	58.4 ± 9.17	59.2 ± 9.03
Gender [units: participants]
Female	47	49	53	59	208
Male	152	151	198	195	696
Race/Ethnicity, Customized [units: participants]
African descent	10	14	15	9	48
Western Asian	3	3	1	3	10
Caucasian	180	180	226	238	824
East/Southeast Asian	1	1	1	0	3
Hispanic	5	2	7	2	16
Other	0	0	1	2	3
Region of Enrollment [units: participants]
Canada	43	44	48	46	181
United States	156	156	203	208	723

Outcome Measures

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1. Primary:

Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

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2. Secondary:

Number of Participants With Major Adverse Cardiovascular Events (MACE) [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

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3. Secondary:

Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

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4. Secondary:

Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

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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
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00059215 History of Changes
Other Study ID Numbers:	7145, H7T-MC-TAAH
Study First Received:	April 21, 2003
Results First Received:	April 19, 2010
Last Updated:	May 21, 2010
Health Authority:	United States: Food and Drug Administration