Coronary Artery DiseasePhase 2PRINCIPLENCT00357968

Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting

A Phase 2 study testing Prasugrel and Clopidogrel in people with Coronary Artery Disease, run by Eli Lilly and Company at 16 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Prasugrel and Clopidogrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 201 participants
Where: 16 sitesin 4 countries
Study dates: Aug 2006to Jun 2007
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
At least one of the following (a through c):
Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
A reversible defect on nuclear imaging.
A reversible wall-motion abnormality by echocardiography.
Horizontal or down-sloping ST-depressions greater than 1 mm on electrocardiogram (ECG) (if no imaging performed).
Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment.

Who cannot join

Known creatine kinase-myocardial bands (CK-MB)or cardiac troponin greater than the upper limit of normal at time of screening
Planned PCI for acute myocardial infarction (MI) or planned PCI within 48 hours of fibrinolytic therapy for ST segment elevation myocardial infarction (STEMI)
Have cardiogenic shock at the time of screening (systolic blood pressure 90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
Refractory ventricular arrhythmias
Have New York Heart Association Class IV congestive heart failure

Trial locations and contacts

16 sites in 4 countries.

Country

City, postcode or hospital

16 sites in 4 countries

Germany5 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 Krozingen, D-79189
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.
Berlin, D-12203
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.
Giessen, 35392
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.
München, D-80636
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Tübingen, 72076

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United States4 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.
Ann Arbor, Michigan, 48109
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Jacksonville, Florida, 32209
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Rapid City, South Dakota, 57701
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Worcester, Massachusetts, 01655

Other trials in United States

France4 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.
Lille, 59037
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.
Marseille, 13385
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.
Paris, 75013
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.
Tours, 37044

Other trials in France

Israel3 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.
Haifa, 31096
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.
Jerusalem, 91120
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.
Tel HaShomer, 52621

Other trials in Israel

About this study

Official title: Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44

Conditions: Coronary Artery Disease
Being tested: Prasugrel, Clopidogrel, Placebo for Prasugrel, Placebo for Clopidogrel
Medical subject headings: Coronary Artery Disease

What participants receive

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

PrasugrelDrug
Also called LY 640315, Effient, Efient
Administered orally
ClopidogrelDrug
Administered orally
Placebo for PrasugrelDrug
Administered orally
Placebo for ClopidogrelDrug
Administered orally

Study groups in NCT00357968
Study group	Role	What they receive
Prasugrel to Clopidogrel	Experimental	One time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days. Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days. Receives: Drug: Prasugrel; Drug: Clopidogrel; Drug: Placebo for Prasugrel; Drug: Placebo for Clopidogrel
Clopidogrel to Prasugrel	Active comparator	One time oral LD of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for 14 days. Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days. Receives: Drug: Prasugrel; Drug: Clopidogrel; Drug: Placebo for Prasugrel; Drug: Placebo for Clopidogrel

What is being measured

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

Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose
IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.
Measured: 6 hours after loading dose
Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment
Measures IPA during maintenance dosing before and after cross-over for each therapy.
IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100.
Measured: after 14 days of maintenance dosing

Secondary outcomes (16)

Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose
IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.
Measured: 2 hours after loading dose
Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase
Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.
Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL.
Measured: after 14 days of treatment (before cross-over)
Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase
Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.
Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL.
Measured: 14 days after cross-over
Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase
Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
Measured: after 14 days of treatment (before cross-over)
Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase
Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
Measured: 14 days after cross-over
Number of Hyporesponsive Participants at 6 Hours After the Loading Dose
Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
Measured: 6 hours after loading dose
Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase
Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
Measured: From loading dose to day 15
Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase
Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
Measured: 14 days after cross-over
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.
Measured: 2 hours after loading dose
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.
Measured: 6 hours after loading dose
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect.
Measured: 18 to 24 hours after loading dose
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment
VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.
Measured: after 14 days of maintenance dosing
Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose
Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis
Measured: 6 hours after loading dose
Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose
Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis.
Measured: 18 to 24 hours after loading dose
Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose
Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis.
Measured: 6 hours after loading dose
Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose
Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis.
Measured: 18 to 24 hours after loading dose

Timeline

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

Aug 2006Jun 2007

First posted28 Jul 2006 (estimated)
Study startAug 2006
Primary completionJun 2007
Study completionJun 2007

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.
Other trials for Coronary Artery DiseaseStudies 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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00357968
Sponsor's protocol ID: 10635
Other IDs: H7T-MC-TABL
Acronym: PRINCIPLE
Status last verified: Aug 2010
First submitted: 26 Jul 2006
Last updated: 31 Aug 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44
ClinicalTrials.gov ID: NCT00357968
Acronym / sponsor ID: PRINCIPLE / 10635
Conditions: Coronary Artery Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo, The TIMI Study Group
Study start: Aug 2006
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 28 Jul 2006 (estimated)
Results: Posted 9 Aug 2010

Clinical summary

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

Study design

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

Arm	Type	Receives
Prasugrel to Clopidogrel	Experimental	Drug: Prasugrel, Drug: Clopidogrel, Drug: Placebo for Prasugrel, Drug: Placebo for ClopidogrelOne time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days. Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days.
Clopidogrel to Prasugrel	Active comparator	Drug: Prasugrel, Drug: Clopidogrel, Drug: Placebo for Prasugrel, Drug: Placebo for ClopidogrelOne time oral LD of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for 14 days. Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days.

Who may qualify

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

Key inclusion criteria (8 listed)

Subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
At least one of the following (a through c):

Key exclusion criteria (5 listed)

Known creatine kinase-myocardial bands (CK-MB)or cardiac troponin greater than the upper limit of normal at time of screening
Planned PCI for acute myocardial infarction (MI) or planned PCI within 48 hours of fibrinolytic therapy for ST segment elevation myocardial infarction (STEMI)
Have cardiogenic shock at the time of screening (systolic blood pressure 90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
Refractory ventricular arrhythmias
Have New York Heart Association Class IV congestive heart failure

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: LY 640315, Effient, EfientAdministered orally	Drug	Clopidogrel to Prasugrel, Prasugrel to Clopidogrel
ClopidogrelAdministered orally	Drug	Clopidogrel to Prasugrel, Prasugrel to Clopidogrel
Placebo for PrasugrelAdministered orally	Drug	Clopidogrel to Prasugrel, Prasugrel to Clopidogrel
Placebo for ClopidogrelAdministered orally	Drug	Clopidogrel to Prasugrel, Prasugrel to Clopidogrel

Primary outcome

Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose
Time frame: 6 hours after loading dose
IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.
Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment
Time frame: after 14 days of maintenance dosing
Measures IPA during maintenance dosing before and after cross-over for each therapy. IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100.

16 secondary outcomes

Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose
Time frame: 2 hours after loading dose
Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase
Time frame: after 14 days of treatment (before cross-over)
Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase
Time frame: 14 days after cross-over
Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase
Time frame: after 14 days of treatment (before cross-over)
Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase
Time frame: 14 days after cross-over
Number of Hyporesponsive Participants at 6 Hours After the Loading Dose
Time frame: 6 hours after loading dose
Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase
Time frame: From loading dose to day 15
Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase
Time frame: 14 days after cross-over
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose
Time frame: 2 hours after loading dose
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose
Time frame: 6 hours after loading dose
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose
Time frame: 18 to 24 hours after loading dose
Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment
Time frame: after 14 days of maintenance dosing
Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose
Time frame: 6 hours after loading dose
Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose
Time frame: 18 to 24 hours after loading dose
Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose
Time frame: 6 hours after loading dose
Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose
Time frame: 18 to 24 hours after loading dose

Results and safety

Results posted to the registry on 9 Aug 2010, 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 to Clopidogrel	102	54
Clopidogrel to Prasugrel	99	55

Primary outcome: Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose

Time frame: 6 hours after loading dose. Mean (Standard Deviation). Unit: percent inhibition

Measure	Prasugrel n = 72	Clopidogrel n = 77
Value	74.81 (13.01)	31.77 (21.07)

Prasugrel vs Clopidogrel: Mean Difference (Net): 43.21 (95% CI 38.04 to 48.38), p <0.0001, ANCOVA

Population analysed: Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.

Primary outcome: Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment

Time frame: after 14 days of maintenance dosing. Mean (Standard Deviation). Unit: percent inhibition

Measure	Prasugrel n = 85	Clopidogrel n = 86
Value	61.34 (17.84)	46.06 (21.34)

Prasugrel vs Clopidogrel: LS Mean difference: 14.93 (95% CI 10.6 to 19.26), p <0.0001, Mixed Models Analysis

Population analysed: Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)

16 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 Before Cross-over	8 of 102 (7.8%)	40 of 102 (39.2%)	Not reported
Clopidogrel Before Cross-over	7 of 99 (7.1%)	40 of 99 (40.4%)	Not reported
Prasugrel After Cross-over	1 of 55 (1.8%)	16 of 55 (29.1%)	Not reported
Clopidogrel After Cross-over	3 of 53 (5.7%)	12 of 53 (22.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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

16 sites in 4 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, run by Eli Lilly and Company at 16 sites in 4 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, United States, France, Israel. 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 9 Aug 2010). 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?

Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose (time frame: 6 hours after loading dose). The study lists 2 primary outcomes in all. 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 NCT00357968.

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 31 Aug 2010.