Acute Coronary SyndromePhase 2NCT00385944

The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

A Phase 2 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome, run by Eli Lilly and Company at 2 sites in France.

Completed

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

Official record

Search all trials

Trial summary

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Prasugrel and Clopidogrel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 2 sitesFrance
Study dates: Mar 2007to Oct 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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
Are between the ages of 18 and 85 years.
Willing and able to sign informed consent.

Who cannot join

Have overt ST-segment elevation myocardial infarction (STEMI).
Have cardiogenic shock.
Have refractory ventricular arrhythmias.
Have New York Heart Association (NYHA) Class IV congestive heart failure.
Have severe and uncontrolled hypertension.
Have active internal bleeding or history of bleeding diathesis.

Show all 10Show fewer

Have an increased risk of bleeding.
Have history of cerebrovascular accidents.
Have certain abnormal blood level values.
Are currently receiving chemotherapy or radiation therapy.

Trial locations and contacts

2 sites in 1 country.

France2 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.
Créteil, 94010
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

Other trials in France

About this study

Official title: A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation

Conditions: Acute Coronary Syndrome
Being tested: Prasugrel, Clopidogrel
Medical subject headings: Acute Coronary Syndrome

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
Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.
ClopidogrelDrug
Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.

Study groups in NCT00385944
Study group	Role	What they receive
Prasugrel	Experimental	Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days. Receives: Drug: Prasugrel
Clopidogrel	Active comparator	Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days. Receives: Drug: Clopidogrel

What is being measured

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

Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).
Measured: 14 days after maintenance dose (MD)

Secondary outcomes (17)

MPA to 5 μM ADP
Maximum platelet aggregation to 5 μM ADP was assessed by LTA.
Measured: 14 days after maintenance dose (MD)
Mean Residual Platelet Aggregation (RPA) to 20 µM ADP
Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.
Measured: 14 days after maintenance dose (MD)
Mean Residual Platelet Aggregation (RPA) to 5 µM ADP
Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.
Measured: 14 days after maintenance dose (MD)
Inhibition Platelet Aggregation (IPA) to 20 μM ADP
IPA is calculated as a percent decrease of MPA from baseline using the following formula:
([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%
Measured: 14 days after maintenance dose (MD)
Inhibition Platelet Aggregation (IPA) to 5 μM ADP
IPA is calculated as a percent decrease of MPA from baseline using the following formula:
([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%
Measured: 14 days after maintenance dose (MD)
Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP
IRPA is calculated as a percent decrease of RPA from baseline using the following formula:
([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%
Measured: 14 days after maintenance dose (MD)
Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP
IRPA is calculated as a percent decrease of RPA from baseline using the following formula:
([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%
Measured: 14 days after maintenance dose (MD)
Platelet Reactivity Index (PRI)
Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:
PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100
Lower PRI% values indicate greater P2Y12 receptor blockade.
Measured: 14 days after maintenance dose (MD)
P2Y12 Reaction Units (PRU)
P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.
Measured: 14 days after maintenance dose (MD)
Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)
Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.
Measured: 14 days after maintenance dose (MD)
Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Measured: Baseline to 6-18 hrs post loading dose (LD)
Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Measured: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)
MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Measured: 14 days after the first maintenance dose (MD)
MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)
Maximum platelet aggregation to 20 μM ADP was assessed by LTA.
Measured: 14 days after the second maintenance dose (MD)
Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.
Measured: 14 days after maintenance dose (MD)
Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.
Measured: 14 days after maintenance dose (MD)
Correlation of MPA to 20 μM ADP and PRU
Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU
Measured: Baseline through 29 days of treatment

Timeline

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

Mar 2007Oct 2007

First posted11 Oct 2006 (estimated)
Study startMar 2007
Primary completionOct 2007
Study completionOct 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 Acute Coronary SyndromeStudies 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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00385944
Sponsor's protocol ID: 10632
Other IDs: H7T-MC-TABN
Status last verified: Aug 2010
First submitted: 6 Oct 2006
Last updated: 16 Sep 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?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation
ClinicalTrials.gov ID: NCT00385944
Acronym / sponsor ID: 10632
Conditions: Acute Coronary Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo
Study start: Mar 2007
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 11 Oct 2006 (estimated)
Results: Posted 16 Sep 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	Experimental	Drug: PrasugrelOpen label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days.
Clopidogrel	Active comparator	Drug: ClopidogrelOpen label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
Are between the ages of 18 and 85 years.
Willing and able to sign informed consent.

Key exclusion criteria (10 listed)

Have overt ST-segment elevation myocardial infarction (STEMI).
Have cardiogenic shock.
Have refractory ventricular arrhythmias.
Have New York Heart Association (NYHA) Class IV congestive heart failure.
Have severe and uncontrolled hypertension.

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, EfientPrasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.	Drug	Prasugrel
ClopidogrelClopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.	Drug	Clopidogrel

Primary outcome

Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
Time frame: 14 days after maintenance dose (MD)
Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).

17 secondary outcomes

MPA to 5 μM ADP
Time frame: 14 days after maintenance dose (MD)
Mean Residual Platelet Aggregation (RPA) to 20 µM ADP
Time frame: 14 days after maintenance dose (MD)
Mean Residual Platelet Aggregation (RPA) to 5 µM ADP
Time frame: 14 days after maintenance dose (MD)
Inhibition Platelet Aggregation (IPA) to 20 μM ADP
Time frame: 14 days after maintenance dose (MD)
Inhibition Platelet Aggregation (IPA) to 5 μM ADP
Time frame: 14 days after maintenance dose (MD)
Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP
Time frame: 14 days after maintenance dose (MD)
Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP
Time frame: 14 days after maintenance dose (MD)
Platelet Reactivity Index (PRI)
Time frame: 14 days after maintenance dose (MD)
P2Y12 Reaction Units (PRU)
Time frame: 14 days after maintenance dose (MD)
Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)
Time frame: 14 days after maintenance dose (MD)
Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)
Time frame: Baseline to 6-18 hrs post loading dose (LD)
Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)
Time frame: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)
MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)
Time frame: 14 days after the first maintenance dose (MD)
MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)
Time frame: 14 days after the second maintenance dose (MD)
Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Time frame: 14 days after maintenance dose (MD)
Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
Time frame: 14 days after maintenance dose (MD)
Correlation of MPA to 20 μM ADP and PRU
Time frame: Baseline through 29 days of treatment

Results and safety

Results posted to the registry on 16 Sep 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/Clopidogrel	0	0
Clopidogrel/Prasugrel	0	0
Loading Dose	56	56

Primary outcome: Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)

Time frame: 14 days after maintenance dose (MD). Mean (Standard Deviation). Unit: Percentage aggregation

Measure	Prasugrel n = 49	Clopidogrel n = 47
Value	27.1 (10.55)	40.3 (14.96)

Prasugrel vs Clopidogrel: Mean Difference (Net): -12.91 (95% CI -17.02 to -8.81), p <0.001, Mixed Models Analysis

Population analysed: The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.

17 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
Clopidogrel 900 mg LD	1 of 56 (1.8%)	20 of 56 (35.7%)	Not reported
Prasugrel 10 mg - 1st MD	3 of 29 (10.3%)	7 of 29 (24.1%)	Not reported
Clopidogrel 150 mg - 1st MD	0 of 25 (0%)	7 of 25 (28%)	Not reported
Clopidogrel 150 mg - Crossover From Prasugrel 10 mg	1 of 24 (4.2%)	3 of 24 (12.5%)	Not reported
Prasugrel 10 mg - Crossover From Clopidogrel 150 mg	1 of 22 (4.5%)	2 of 22 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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

2 sites in 1 country: 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 Acute Coronary Syndrome, run by Eli Lilly and Company at 2 sites in France.

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 3 inclusion and 10 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 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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 16 Sep 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?

Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) (time frame: 14 days after maintenance dose (MD)). 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 NCT00385944.

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 16 Sep 2010; AzTrials last refreshed its copy on 26 Oct 2026.