Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event - Study Results

Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event (SWAP)

This study has been completed.

Study NCT00356135 Information provided by Eli Lilly and Company

First Received on July 21, 2006. Last Updated on October 20, 2010 History of Changes

Results First Received: December 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Coronary Arteriosclerosis Acute Coronary Syndrome
Interventions:	Drug: prasugrel 10 mg Drug: clopidogrel Drug: prasugrel placebo Drug: prasugrel 60 mg Drug: clopidogrel placebo

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
30-330 days after acute coronary syndrome event, patients participated in 2 week open-label clopidogrel phase. Patients were then randomized to either 22-26 hour loading doses of: 60-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, then continued 2-week maintenance phase of 10-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, respectively.

Reporting Groups

	Description
Prasgurel 10/10 mg	Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
Clopidogrel 75/75 mg	Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
Prasugrel 60/10 mg	Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

Participant Flow: Overall Study

	Prasgurel 10/10 mg	Clopidogrel 75/75 mg	Prasugrel 60/10 mg
STARTED	47	48	44
COMPLETED	43	46	39
NOT COMPLETED	4	2	5
Protocol Violation	1	0	0
Adverse Event	1	0	0
Lost to Follow-up	0	0	1
Physician Decision	1	1	1
Subject non-compliance	1	1	3

Baseline Characteristics

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Reporting Groups

	Description
Prasugrel 10/10 mg	Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
Clopidogrel 75/75 mg	Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
Prasugrel 60/10 mg	Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

Baseline Measures

	Prasugrel 10/10 mg	Clopidogrel 75/75 mg	Prasugrel 60/10 mg	Total
Number of Participants [units: participants]	47	48	44	139
Age [units: years] Mean ± Standard Deviation	57.6 ± 8.18	56.9 ± 8.93	58.7 ± 9.16	57.7 ± 8.73
Gender [units: participants]
Female	12	18	15	45
Male	35	30	29	94
Race/Ethnicity, Customized ^[1] [units: participants]
Caucasian	39	30	37	106
African	7	13	6	26
Asian	0	0	0	0
Other	1	5	1	7
Region of Enrollment [units: participants]
United States	47	48	44	139

[1]	breakdown of participants by race/ethnicity

Outcome Measures

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1. Primary:

Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP) [ Time Frame: 1 week after first dose of randomized study drug ]

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2. Secondary:

Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks [ Time Frame: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug ]

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3. Secondary:

Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event [ Time Frame: End of 14 day open label ]

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4. Secondary:

Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks [ Time Frame: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug ]

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5. Secondary:

Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week [ Time Frame: 1 week after randomized study drug ]

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6. Secondary:

Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria [ Time Frame: End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug ]

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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

Publications of Results:

Angiolillo DJ, Saucedo JF, Deraad R, Frelinger AL, Gurbel PA, Costigan TM, Jakubowski JA, Ojeh CK, Effron MB; SWAP Investigators. Increased platelet inhibition after switching from maintenance clopidogrel to prasugrel in patients with acute coronary syndromes: results of the SWAP (SWitching Anti Platelet) study. J Am Coll Cardiol. 2010 Sep 21;56(13):1017-23.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00356135 History of Changes
Other Study ID Numbers:	10631, H7T-MC-TABM
Study First Received:	July 21, 2006
Results First Received:	December 10, 2009
Last Updated:	October 20, 2010
Health Authority:	United States: Food and Drug Administration