Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)

This study has been terminated.

(Due to the low rate of primary endpoint events experienced in the study to date)

Sponsor:

Collaborator:

Daiichi Sankyo Co., Ltd.

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00910299

First received: May 28, 2009

Last updated: May 8, 2012

Last verified: April 2012

History of Changes

Results First Received: April 10, 2012

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:	Coronary Artery Disease (CAD)
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
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Reporting Groups

	Description
Prasugrel	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
Clopidogrel	75 mg oral daily maintenance dose up to 6 months.

Participant Flow: Overall Study

	Prasugrel	Clopidogrel
STARTED	212	211
Received at Least 1 Dose of Study Drug	210	210
COMPLETED	136	137 ^[1]
NOT COMPLETED	76	74
Withdrawal by Subject	16	13
Sponsor Decision	58	60
Didn't receive any study drug	2	1

[1]	1 participant died of sepsis while on study drug and was considered a “protocol completer.”

Baseline Characteristics

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Reporting Groups

	Description
Prasugrel	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
Clopidogrel	75 mg oral daily maintenance dose up to 6 months.
Total	Total of all reporting groups

Baseline Measures

	Prasugrel	Clopidogrel	Total
Number of Participants [units: participants]	212	211	423
Age [units: years] Mean ± Standard Deviation	65.8 ± 8.3	66.3 ± 8.6	66.1 ± 8.4
Gender [units: participants]
Female	59	57	116
Male	153	154	307
Race/Ethnicity, Customized [units: participants]
Asian	1	1	2
Black or African American	0	3	3
White	211	207	418
Region of Enrollment [units: participants]
United States	12	13	25
Germany	200	198	398

Outcome Measures

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1. Primary:

Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI) [ Time Frame: Baseline through 6 months ]

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2. Secondary:

Number of Participants With Stent Thrombosis (ST) [ Time Frame: Baseline through 6 months ]

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3. Secondary:

Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI) [ Time Frame: Baseline through 6 months ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Prasugrel	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
Clopidogrel	75 mg oral daily maintenance dose up to 6 months.

Serious Adverse Events

	Prasugrel	Clopidogrel
Total, serious adverse events
# participants affected / at risk	40/210 (19.05%)	38/210 (18.10%)
Cardiac disorders
Angina pectoris ^{† 1}
# participants affected / at risk	6/210 (2.86%)	2/210 (0.95%)
# events	6	2
Angina unstable ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Arrhythmia ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Atrial fibrillation ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Atrioventricular block second degree ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Bradycardia ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Cardiac failure ^{† 1}
# participants affected / at risk	1/210 (0.48%)	2/210 (0.95%)
# events	1	2
Cardiac failure acute ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Cardiac failure congestive ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Coronary artery stenosis ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Mitral valve incompetence ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Pericardial effusion ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Ventricular tachycardia ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Ear and labyrinth disorders
Deafness ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Gastrointestinal disorders
Gastric ulcer ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Gastritis ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Gastritis erosive ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Gastrointestinal haemorrhage ^{† 1}
# participants affected / at risk	1/210 (0.48%)	1/210 (0.48%)
# events	1	1
Melaena ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Rectal haemorrhage ^{† 1}
# participants affected / at risk	1/210 (0.48%)	1/210 (0.48%)
# events	1	1
Vomiting ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
General disorders
Catheter site haemorrhage ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Chest pain ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Non-cardiac chest pain ^{† 1}
# participants affected / at risk	2/210 (0.95%)	5/210 (2.38%)
# events	2	5
Infections and infestations
Arthritis infective ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Bronchitis ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Cellulitis ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Clostridium difficile colitis ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	2
Diverticulitis ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Erysipelas ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Gastroenteritis norovirus ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Nasopharyngitis ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Sepsis ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Viral infection ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Injury, poisoning and procedural complications
Contusion ^{† 1}
# participants affected / at risk	0/210 (0.00%)	2/210 (0.95%)
# events	0	2
In-stent coronary artery restenosis ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Spinal compression fracture ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Vascular pseudoaneurysm ^{† 1}
# participants affected / at risk	1/210 (0.48%)	1/210 (0.48%)
# events	1	1
Investigations
Blood creatine phosphokinase increased ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Blood creatinine increased ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Troponin increased ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Metabolism and nutrition disorders
Hyperglycaemia ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Musculoskeletal and connective tissue disorders
Gouty arthritis ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Intervertebral disc protrusion ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Musculoskeletal chest pain ^{† 1}
# participants affected / at risk	1/210 (0.48%)	1/210 (0.48%)
# events	1	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Burkitt's lymphoma ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Oropharyngeal cancer stage unspecified ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Ovarian adenoma ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Nervous system disorders
Hypoglycaemic coma ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Ischaemic stroke ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Neuralgia ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Syncope ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Transient ischaemic attack ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Psychiatric disorders
Alcohol abuse ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Depression ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	2
Panic attack ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Renal and urinary disorders
Renal impairment ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	2	0
Dyspnoea ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Dyspnoea exertional ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Pleural effusion ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Skin and subcutaneous tissue disorders
Rash ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Surgical and medical procedures
Coronary revascularisation ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Percutaneous coronary intervention ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Vascular disorders
Aortic aneurysm ^{† 1}
# participants affected / at risk	0/210 (0.00%)	2/210 (0.95%)
# events	0	2
Deep vein thrombosis ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Hypertension ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	1	0
Hypertensive crisis ^{† 1}
# participants affected / at risk	3/210 (1.43%)	2/210 (0.95%)
# events	3	2
Intermittent claudication ^{† 1}
# participants affected / at risk	1/210 (0.48%)	0/210 (0.00%)
# events	2	0
Peripheral arterial occlusive disease ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1
Peripheral artery aneurysm ^{† 1}
# participants affected / at risk	0/210 (0.00%)	1/210 (0.48%)
# events	0	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 13.1

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
The study was terminated early, and no formal statistical time-to-event analysis was performed.

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:

Trenk D, Stone GW, Gawaz M, Kastrati A, Angiolillo DJ, Müller U, Richardt G, Jakubowski JA, Neumann FJ. A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents: results of the TRIGGER-PCI (Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel) study. J Am Coll Cardiol. 2012 Jun 12;59(24):2159-64. Epub 2012 Apr 18.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00910299 History of Changes
Other Study ID Numbers:	12323, H7T-MC-TACW
Study First Received:	May 28, 2009
Results First Received:	April 10, 2012
Last Updated:	May 8, 2012
Health Authority:	United States: Food and Drug Administration

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