Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

This study has been terminated.

(The trial was terminated at the request of the Data and Safety Monitoring Board.)

Sponsor:

Collaborator:

Duke Clinical Research Institute

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00527943

First received: September 7, 2007

Last updated: March 31, 2017

Last verified: March 2017

History of Changes

Results First Received: May 9, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Atherosclerosis Myocardial Ischemia Myocardial Infarction
Interventions:	Drug: Vorapaxar Drug: 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
Prior to the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time. However, follow-up in the study was terminated earlier than planned.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.

Reporting Groups

	Description
Placebo	Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar	Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Participant Flow: Overall Study

	Placebo	Vorapaxar
STARTED	6471	6473
Received Treatment	6441	6446
COMPLETED	6311	6327
NOT COMPLETED	160	146

Baseline Characteristics

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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.
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Reporting Groups

	Description
Placebo	Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar	Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Vorapaxar	Total
Overall Participants Analyzed [Units: Participants]	6471	6473	12944

Age, Customized [Units: Participants]
<65 years	3369	3390	6759
65 to <75 years	2006	1973	3979
>= 75 years	1096	1110	2206

Sex: Female, Male [Units: Participants] Count of Participants
Female	1822 28.2%	1810 28.0%	3632 28.1%
Male	4649 71.8%	4663 72.0%	9312 71.9%

Outcome Measures

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1. Primary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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2. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization [ Time Frame: up to 2 years ]

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3. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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4. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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5. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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6. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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7. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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8. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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9. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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10. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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11. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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12. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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13. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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14. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
Prior to the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time.

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. Restriction Description: All draft publications will be submitted to the Publication Committee for review. Full-length papers will be submitted at least 45 days prior to submission to a journal. Abstracts or public presentations (eg, poster) will be submitted at least 14 days in advance.

Results Point of Contact:

Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Storey RF, Kotha J, Smyth SS, Moliterno DJ, Rorick TL, Moccetti T, Valgimigli M, Dery JP, Cornel JH, Thomas GS, Huber K, Harrington RA, Hord E, Judge HM, Chen E, Strony J, Mahaffey KW, Tricoci P, Becker RC, Jennings LK. Effects of vorapaxar on platelet reactivity and biomarker expression in non-ST-elevation acute coronary syndromes. The TRACER Pharmacodynamic Substudy. Thromb Haemost. 2014 May 5;111(5):883-91. doi: 10.1160/TH13-07-0624. Epub 2014 Jan 9.

Valgimigli M, Tricoci P, Huang Z, Aylward PE, Armstrong PW, Van de Werf F, Leonardi S, White HD, Widimsky P, Harrington RA, Cequier A, Chen E, Lokhnygina Y, Wallentin L, Strony J, Mahaffey KW, Moliterno DJ. Usefulness and safety of vorapaxar in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention (from the TRACER Trial). Am J Cardiol. 2014 Sep 1;114(5):665-73. doi: 10.1016/j.amjcard.2014.05.054. Epub 2014 Jun 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Popma CJ, Sheng S, Korjian S, Daaboul Y, Chi G, Tricoci P, Huang Z, Moliterno DJ, White HD, Van de Werf F, Harrington RA, Wallentin L, Held C, Armstrong PW, Aylward PE, Strony J, Mahaffey KW, Gibson CM. Lack of Concordance Between Local Investigators, Angiographic Core Laboratory, and Clinical Event Committee in the Assessment of Stent Thrombosis: Results From the TRACER Angiographic Substudy. Circ Cardiovasc Interv. 2016 May;9(5):e003114. doi: 10.1161/CIRCINTERVENTIONS.115.003114.

Vranckx P, White HD, Huang Z, Mahaffey KW, Armstrong PW, Van de Werf F, Moliterno DJ, Wallentin L, Held C, Aylward PE, Cornel JH, Bode C, Huber K, Nicolau JC, Ruzyllo W, Harrington RA, Tricoci P. Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes: The TRACER Trial. J Am Coll Cardiol. 2016 May 10;67(18):2135-44. doi: 10.1016/j.jacc.2016.02.056.

Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

Bagai A, Huang Z, Lokhnygina Y, Harrington RA, Armstrong PW, Strony J, White HD, Leonardi S, Held C, Van de Werf F, Wallentin L, Tricoci P, Mahaffey KW. Magnitude of troponin elevation and long-term clinical outcomes in acute coronary syndrome patients treated with and without revascularization. Circ Cardiovasc Interv. 2015 Jun;8(6):e002314. doi: 10.1161/CIRCINTERVENTIONS.115.002314.

White HD, Huang Z, Tricoci P, Van de Werf F, Wallentin L, Lokhnygina Y, Moliterno DJ, Aylward PE, Mahaffey KW, Armstrong PW. Reduction in overall occurrences of ischemic events with vorapaxar: results from TRACER. J Am Heart Assoc. 2014 Jul 10;3(4). pii: e001032. doi: 10.1161/JAHA.114.001032.

Whellan DJ, Tricoci P, Chen E, Huang Z, Leibowitz D, Vranckx P, Marhefka GD, Held C, Nicolau JC, Storey RF, Ruzyllo W, Huber K, Sinnaeve P, Weiss AT, Dery JP, Moliterno DJ, Van de Werf F, Aylward PE, White HD, Armstrong PW, Wallentin L, Strony J, Harrington RA, Mahaffey KW. Vorapaxar in acute coronary syndrome patients undergoing coronary artery bypass graft surgery: subgroup analysis from the TRACER trial (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome). J Am Coll Cardiol. 2014 Mar 25;63(11):1048-57. doi: 10.1016/j.jacc.2013.10.048. Epub 2013 Nov 21.

Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20-33. doi: 10.1056/NEJMoa1109719. Epub 2011 Nov 13.

TRA*CER Executive and Steering Committees. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale. Am Heart J. 2009 Sep;158(3):327-334.e4. doi: 10.1016/j.ahj.2009.07.001. Erratum in: Am Heart J. 2010 May;159(5):932.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00527943 History of Changes
Other Study ID Numbers:	P04736 TRA•CER 2006-002809-31 MK-5348-014 ( Other Identifier: Merck Study Number )
Study First Received:	September 7, 2007
Results First Received:	May 9, 2014
Last Updated:	March 31, 2017

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