Coronary Artery Disease (CAD)Phase 2TRIGGER-PCINCT00910299

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

A Phase 2 study testing Prasugrel and Clopidogrel in people with Coronary Artery Disease (CAD), run by Eli Lilly and Company at 27 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Coronary Artery Disease (CAD)
What is being tested?: Prasugrel and Clopidogrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 423 participants
Where: 27 sitesin 2 countries
Study dates: Jul 2009to Apr 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

27 sites in 2 countries.

Country

City, postcode or hospital

27 sites in 2 countries

Germany18 sites

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.
Bad Berka, 99437
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Bad Krozingen, 79189
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Bad Segeberg, 23795
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Berlin, 12203
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Bremen, 28277
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Dortmund, 44137
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Essen, 45147
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Freiburg im Breisgau, 79106
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Fulda, 36043
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Hamburg, 20246
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Leipzig, 04289
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Mainz, 55131
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Munich, 80636
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Pforzheim, 75175
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Stuttgart, 70376
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Tübingen, 72076
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Villingen-Schwenningen, 78050
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Wuppertal, 42117

Other trials in Germany

United States9 sites

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.
Clearwater, Florida, 33756
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Jacksonville, Florida, 32209
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Moline, Illinois, 61265
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Nashville, Tennessee, 37203
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.
New York, New York, 10021
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Pittsburgh, Pennsylvania, 15213
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.
Portland, Oregon, 97225
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.
Rapid City, South Dakota, 55701
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.
Rome, Georgia, 30165

Other trials in United States

About this study

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

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.

Conditions: Coronary Artery Disease (CAD)
Being tested: Prasugrel, Clopidogrel
Keywords: Clopidogrel, VerifyNow, PRU Measurements, Drug Eluting Stents (DES), Heart Disease, Percutaneous Coronary Intervention (PCI), P2Y12, Platelets, Platelet Reactivity
Medical subject headings: Coronary Artery Disease, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrasugrelDrug
Also called LY640315, Effient, Efient
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
ClopidogrelDrug
75 mg oral daily maintenance dose up to 6 months.

Study groups in NCT00910299
Study group	Role	What they receive
Prasugrel	Experimental	Not described Receives: Drug: Prasugrel
Clopidogrel	Active comparator	Not described Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline through 6 months

Secondary outcomes (2)

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.
Measured: Baseline through 6 months
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.
Measured: Baseline through 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Apr 2011

First posted29 May 2009 (estimated)
Study startJul 2009
Primary completionApr 2011
Study completionApr 2011

Why it stopped: Due to the low rate of primary endpoint events experienced in the study to date

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 423 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00910299
Sponsor's protocol ID: 12323
Other IDs: H7T-MC-TACW
Acronym: TRIGGER-PCI
Status last verified: Apr 2012
First submitted: 28 May 2009
Last updated: 8 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 22520250

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00910299
Acronym / sponsor ID: TRIGGER-PCI / 12323
Conditions: Coronary Artery Disease (CAD)
Keywords: Clopidogrel, VerifyNow, PRU Measurements, Drug Eluting Stents (DES), Heart Disease, Percutaneous Coronary Intervention (PCI), P2Y12, Platelets
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the low rate of primary endpoint events experienced in the study to date
Enrolment: 423 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo Co., Ltd.
Study start: Jul 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 29 May 2009 (estimated)
Results: Posted 8 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Prasugrel	Experimental	Drug: Prasugrel
Clopidogrel	Active comparator	Drug: Clopidogrel

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrasugrelAlso: LY640315, Effient, EfientOne time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.	Drug	Prasugrel
Clopidogrel75 mg oral daily maintenance dose up to 6 months.	Drug	Clopidogrel

Primary outcome

Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
Time frame: Baseline through 6 months
The endpoint in this measure is a combination of cardiovascular death or MI.

2 secondary outcomes

Number of Participants With Stent Thrombosis (ST)
Time frame: Baseline through 6 months
Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)
Time frame: Baseline through 6 months

Results and safety

Results posted to the registry on 8 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prasugrel	212	136
Clopidogrel	211	137

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

Time frame: Baseline through 6 months. Number. Unit: participants

Measure	Prasugrel n = 212	Clopidogrel n = 211
Value	0	1

Population analysed: Participants who were randomized.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prasugrel	40 of 210 (19%)	110 of 210 (52.4%)	Not reported
Clopidogrel	38 of 210 (18.1%)	72 of 210 (34.3%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early, and no formal statistical time-to-event analysis was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22520250Trenk 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.

Related trials for Coronary Artery Disease (CAD)

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Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

27 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prasugrel and Clopidogrel in people with Coronary Artery Disease (CAD), run by Eli Lilly and Company at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI) (time frame: Baseline through 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.