A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (TRILOGY ACS)

This study has been completed.

Sponsor:

Collaborators:

Daiichi Sankyo Co., Ltd.

Duke Clinical Research Institute

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00699998

First received: June 16, 2008

Last updated: March 21, 2013

Last verified: March 2013

History of Changes

Results First Received: March 21, 2013

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
Condition:	Acute Coronary Syndrome
Interventions:	Drug: Clopidogrel Drug: Prasugrel Drug: Commercially-available Aspirin

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: <75 Years of Age	Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
Prasugrel: 75 Years of Age or Older	Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
Clopidogrel: <75 Years of Age	Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study
Clopidogrel: 75 Years of Age or Older	Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.

Participant Flow: Overall Study

	Prasugrel: <75 Years of Age	Prasugrel: 75 Years of Age or Older	Clopidogrel: <75 Years of Age	Clopidogrel: 75 Years of Age or Older
STARTED	3620	1043	3623	1040
Received at Least 1 Dose of Study Drug	3590	1033	3590	1027
COMPLETED	3421	957	3417	958
NOT COMPLETED	199	86	206	82
Withdrawal by Subject	194	83	202	80
Physician Decision	3	2	1	1
Lost to Follow-up	2	1	3	1

Baseline Characteristics

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Reporting Groups

	Description
Prasugrel: <75 Years of Age	Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
Prasugrel: 75 Years of Age or Older	Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
Clopidogrel: <75 Years of Age	Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Clopidogrel: 75 Years of Age or Older	Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
Total	Total of all reporting groups

Baseline Measures

	Prasugrel: <75 Years of Age	Prasugrel: 75 Years of Age or Older	Clopidogrel: <75 Years of Age	Clopidogrel: 75 Years of Age or Older	Total
Number of Participants [units: participants]	3620	1043	3623	1040	9326
Age [units: years] Mean ± Standard Deviation	61.4 ± 8.55	80.3 ± 4.29	61.5 ± 8.38	80.3 ± 4.39	65.7 ± 11.02
Gender [units: participants]
Female	1309	520	1290	531	3650
Male	2311	523	2333	509	5676
Race/Ethnicity, Customized [units: participants]
Caucasian	2362	767	2374	773	6276
African	87	14	72	12	185
Hispanic	321	109	346	86	862
Asian	821	147	800	164	1932
Other	29	6	30	5	70
Unknown	0	0	1	0	1
Region of Enrollment [units: participants]
Portugal	18	11	14	11	54
Philippines	58	7	48	14	127
Taiwan	6	6	4	9	25
Slovakia	62	20	60	20	162
Greece	14	8	10	11	43
Costa Rica	5	1	2	2	10
Thailand	30	17	36	10	93
Ukraine	326	28	311	42	707
Chile	28	15	33	13	89
Italy	71	44	70	47	232
India	513	56	508	64	1141
France	29	22	29	19	99
Denmark	21	7	17	10	55
Korea, Republic of	35	7	33	7	82
Panama	29	7	24	10	70
Turkey	76	24	81	19	200
Czech Republic	37	31	32	38	138
Mexico	38	15	40	16	109
Canada	58	14	61	13	146
Brazil	154	27	147	34	362
Romania	103	26	105	23	257
Croatia	63	28	60	31	182
Sweden	4	3	6	1	14
United States	430	133	446	116	1125
Serbia	42	4	40	5	91
Spain	13	8	10	12	43
Ireland	5	4	6	3	18
Israel	75	33	85	21	214
Russian Federation	128	22	135	14	299
Colombia	40	21	45	17	123
Switzerland	6	4	4	6	20
Malaysia	35	7	33	9	84
Peru	58	19	67	12	156
Australia	13	6	15	7	41
South Africa	27	11	27	12	77
Netherlands	55	23	53	24	155
Tunisia	20	3	20	4	47
China	126	38	120	44	328
Finland	3	3	5	2	13
Lithuania	29	8	32	4	73
Austria	6	6	6	5	23
Malta	9	1	10	2	22
United Kingdom	33	21	40	12	106
Egypt	65	1	62	4	132
Hungary	86	43	87	44	260
Argentina	120	58	138	41	357
Poland	137	59	129	68	393
Belgium	7	7	7	8	29
Singapore	2	5	5	1	13
Bulgaria	216	48	209	55	528
Germany	46	20	46	21	133
New Zealand	10	3	10	3	26
History of Diabetes [units: participants]
Yes	1393	363	1418	365	3539
No	2221	678	2193	675	5767
Unknown	6	2	12	0	20
History of Myocardial Infarction (MI) [units: participants]
Yes	1556	426	1612	393	3987
No	2035	603	1988	633	5259
Unknown	29	14	23	14	80
History of Coronary Revascularization (PCI or CABG) ^[1] [units: participants]
Yes	1279	330	1365	299	3273
No	2332	703	2239	734	6008
Unknown	9	10	19	7	45
Clinical Presentation of UA or NSTEMI ^[2] [units: participants]
Unstable Angina	963	166	981	192	2302
Non-ST-segment Elevation Myocardial Infarction	2453	829	2434	804	6520
Unknown/Did not meet criteria	204	48	208	44	504

[1]	History of Coronary Revascularization due to percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
[2]	Clinical Presentation of unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI)

Outcome Measures

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1. Primary:

Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke [ Time Frame: Randomization through end of study (30-month visit) ]

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2. Secondary:

Percentage of Participants With a Composite Endpoint of CV Death and MI [ Time Frame: Randomization through end of study (30-month visit) ]

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3. Secondary:

Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) [ Time Frame: Randomization through end of study (30-month visit) ]

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4. Secondary:

Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke [ Time Frame: Randomization through end of study (30-month visit) ]

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5. Secondary:

Platelet Aggregation Measures [ Time Frame: Day 30 and 12 Months ]

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6. Secondary:

Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) [ Time Frame: Day 30 and 6 Months ]

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7. Secondary:

Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) [ Time Frame: Day 30 and Month 6 ]

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8. Secondary:

Genotyping Related to Drug Metabolism [ Time Frame: Baseline ]

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9. Secondary:

Economic and Quality of Life Outcomes [ Time Frame: Baseline and follow-up (24 months) ]

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10. Secondary:

Summary of All Deaths [ Time Frame: Randomization through end of study (30-month visit) ]

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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
No text entered.

Results Point of Contact:

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

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.

Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteză M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.

Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. Epub 2012 Jul 12.

Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00699998 History of Changes
Other Study ID Numbers:	11058, H7T-MC-TABY(b)
Study First Received:	June 16, 2008
Results First Received:	March 21, 2013
Last Updated:	March 21, 2013
Health Authority:	United States: Food and Drug Administration

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