The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

This study has been completed.

Study NCT00385944 Information provided by Eli Lilly and Company

First Received on October 6, 2006. Last Updated on August 25, 2010 History of Changes

Results First Received: April 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acute Coronary Syndrome
Interventions:	Drug: Prasugrel 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
A total of 56 patients received a clopidogrel loading dose (LD) of 900 mg and were then randomized to receive a maintenance dose (MD) of either 10-mg prasugrel or 150-mg clopidogrel. Two patients withdrew from the study after randomization but prior to receiving a MD, one due to subject decision and one due to physician decision.

Reporting Groups

	Description
Prasugrel/Clopidogrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
Clopidogrel/Prasugrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
Loading Dose	Clopidogrel 900-mg Loading Dose (a single or cumulative dose)

Participant Flow for 3 periods

Period 1: Loading Dose

	Prasugrel/Clopidogrel	Clopidogrel/Prasugrel	Loading Dose
STARTED	0	0	56
COMPLETED	0	0	56
NOT COMPLETED	0	0	0

Period 2: 1st Maintenance Dose Period

	Prasugrel/Clopidogrel	Clopidogrel/Prasugrel
STARTED	29	25 ^[1]
COMPLETED	25	24
NOT COMPLETED	4	1
Physician Decision	1	0
Entry Criteria Exclusion	0	1
Invalid Pharmacodynamic Data	3	0

[1]	Two patients withdrew from the study after randomization but prior to receiving the 1st MD.

Period 3: 2nd Maintenance Dose Period

	Prasugrel/Clopidogrel	Clopidogrel/Prasugrel
STARTED	24 ^[1]	22 ^[2]
COMPLETED	22	19
NOT COMPLETED	2	3
Invalid PD Data	2	3

[1]	1 patient discontinued prior to the 2nd MD Period (Sponsor decision due to early study termination)
[2]	2 patients discontinued prior to the 2nd MD Period (Sponsor decision due to early study termination)

Baseline Characteristics

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Reporting Groups

	Description
Prasugrel/Clopidogrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
Clopidogrel/Prasugrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.

Baseline Measures

	Prasugrel/Clopidogrel	Clopidogrel/Prasugrel	Total
Number of Participants [units: participants]	29	27	56
Age [units: years] Mean ± Standard Deviation	63 ± 13.7	58 ± 10.7	61 ± 12.4
Gender [units: participants]
Female	3	6	9
Male	26	21	47
Race/Ethnicity, Customized [units: Participants]
Caucasian	28	25	53
African	1	2	3
Region of Enrollment [units: participants]
France	29	27	56

Outcome Measures

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1. Primary:

Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) [ Time Frame: 14 days after maintenance dose (MD) ]

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2. Secondary:

MPA to 5 μM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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3. Secondary:

Mean Residual Platelet Aggregation (RPA) to 20 µM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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4. Secondary:

Mean Residual Platelet Aggregation (RPA) to 5 µM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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5. Secondary:

Inhibition Platelet Aggregation (IPA) to 20 μM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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6. Secondary:

Inhibition Platelet Aggregation (IPA) to 5 μM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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7. Secondary:

Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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8. Secondary:

Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP [ Time Frame: 14 days after maintenance dose (MD) ]

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9. Secondary:

Platelet Reactivity Index (PRI) [ Time Frame: 14 days after maintenance dose (MD) ]

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10. Secondary:

P2Y12 Reaction Units (PRU) [ Time Frame: 14 days after maintenance dose (MD) ]

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11. Secondary:

Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD) [ Time Frame: 14 days after maintenance dose (MD) ]

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12. Secondary:

Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD) [ Time Frame: Baseline to 6-18 hrs post loading dose (LD) ]

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13. Secondary:

Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD) [ Time Frame: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD) ]

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14. Secondary:

MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD) [ Time Frame: 14 days after the first maintenance dose (MD) ]

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15. Secondary:

MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD) [ Time Frame: 14 days after the second maintenance dose (MD) ]

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16. Secondary:

Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria [ Time Frame: 14 days after maintenance dose (MD) ]

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17. Secondary:

Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) [ Time Frame: 14 days after maintenance dose (MD) ]

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18. Secondary:

Correlation of MPA to 20 μM ADP and PRU [ Time Frame: Baseline through 29 days of treatment ]

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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:	NCT00385944 History of Changes
Other Study ID Numbers:	10632, H7T-MC-TABN
Study First Received:	October 6, 2006
Results First Received:	April 19, 2010
Last Updated:	August 25, 2010
Health Authority:	United States: Food and Drug Administration