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

Primary Purpose

Coronary Artery Disease (CAD)

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Prasugrel

Clopidogrel

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD) focused on measuring Clopidogrel, VerifyNow, PRU Measurements, Drug Eluting Stents (DES), Heart Disease, Percutaneous Coronary Intervention (PCI), P2Y12, Platelets, Platelet Reactivity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful.
Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI.
Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI.
VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.

Exclusion Criteria:

Non-ST segment elevation myocardial infarction within 14 days prior to randomization
ST-segment elevation myocardial infarction within 14 days prior to randomization
Have known major complications after percutaneous coronary intervention and prior to randomization
Have a body weight < 60 kilogram (kg)
Have cardiogenic shock at time of randomization
Have refractory ventricular arrhythmias
Have New York Heart Association Class IV congestive heart failure
Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention
Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel

Clopidogrel

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)

The endpoint in this measure is a combination of cardiovascular death or MI.

Secondary Outcome Measures

Number of Participants With Stent Thrombosis (ST)

Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.

Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)

The endpoint in this measure is a combination of all-cause death or MI.

Full Information

NCT ID

NCT00910299

First Posted

May 28, 2009

Last Updated

May 8, 2012

Sponsor

Eli Lilly and Company

Collaborators

Daiichi Sankyo Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00910299

Brief Title

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

Acronym

TRIGGER-PCI

Official Title

Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

July 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents. To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents. To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease (CAD)

Keywords

Clopidogrel, VerifyNow, PRU Measurements, Drug Eluting Stents (DES), Heart Disease, Percutaneous Coronary Intervention (PCI), P2Y12, Platelets, Platelet Reactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

423 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Experimental

Arm Title

Clopidogrel

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Other Intervention Name(s)

LY640315, Effient, Efient

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

75 mg oral daily maintenance dose up to 6 months.

Primary Outcome Measure Information:

Title

Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)

Description

The endpoint in this measure is a combination of cardiovascular death or MI.

Time Frame

Baseline through 6 months

Secondary Outcome Measure Information:

Title

Number of Participants With Stent Thrombosis (ST)

Description

Time Frame

Baseline through 6 months

Title

Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)

Description

The endpoint in this measure is a combination of all-cause death or MI.

Time Frame

Baseline through 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful. Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI. Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI. VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI. Exclusion Criteria: Non-ST segment elevation myocardial infarction within 14 days prior to randomization ST-segment elevation myocardial infarction within 14 days prior to randomization Have known major complications after percutaneous coronary intervention and prior to randomization Have a body weight < 60 kilogram (kg) Have cardiogenic shock at time of randomization Have refractory ventricular arrhythmias Have New York Heart Association Class IV congestive heart failure Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

City

Moline

State/Province

Illinois

ZIP/Postal Code

61265

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

55701

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

Facility Name

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

City

Bad Segeberg

ZIP/Postal Code

23795

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

City

Bremen

ZIP/Postal Code

28277

Country

Germany

Facility Name

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Fulda

ZIP/Postal Code

36043

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

City

Munich

ZIP/Postal Code

80636

Country

Germany

Facility Name

City

Pforzheim

ZIP/Postal Code

75175

Country

Germany

Facility Name

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Villingen-Schwenningen

ZIP/Postal Code

78050

Country

Germany

Facility Name

City

Wuppertal

ZIP/Postal Code

42117

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22520250

Citation

Trenk D, Stone GW, Gawaz M, Kastrati A, Angiolillo DJ, Muller 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. doi: 10.1016/j.jacc.2012.02.026. Epub 2012 Apr 18.

Results Reference

derived

Learn more about this trial

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

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