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CompletedNCT00059215Updated May 25, 2010Results posted

A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)

A Phase 2 interventional study of Prasugrel (CS-747) and Clopidogrel in Cardiovascular Diseases and Heart Diseases, sponsored by Eli Lilly and Company. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-05-25.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
905
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 905 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must be candidates for elective or urgent PCI with intended coronary stenting.
  • Men or non-pregnant women (that is, postmenopausal women, women who are surgically sterile, or women of childbearing potential who have a negative urine or serum pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years of age.

Exclusion criteria

Exclusion Criteria:

  • Patients must not have planned PCI procedure as initial treatment for an acute ST-elevation acute myocardial infarction (STEMI)
  • Patients must not be receiving or will receive oral anticoagulation therapy that cannot be safely discontinued for the duration of the study
  • Patients must not have cardiogenic shock or severe congestive heart failure
  • Patients must not have active internal bleeding or history of bleeding diathesis
  • Patients must not have prior history of hemorrhagic cerebrovascular accident (CVA) or nonhemorrhagic CVA within 2 years of enrollment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
905 participants (actual)

Study arms

  • Experimental
    Prasugrel (CS-747) 40 mg LD/7.5 mg MD

    Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days

    Drug: Prasugrel (CS-747)

  • Experimental
    Prasugrel (CS-747) 60 mg LD/10 mg MD

    Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days

    Drug: Prasugrel (CS-747)

  • Experimental
    Prasugrel (CS-747) 60 mg LD/15 mg MD

    Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days

    Drug: Prasugrel (CS-747)

  • Active comparator
    Clopidogrel

    Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

    Drug: Clopidogrel

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events

    Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.

    Time frame: randomization though 30 days after percutaneous coronary intervention (PCI)

Secondary outcomes

  1. Number of Participants With Major Adverse Cardiovascular Events (MACE)

    Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.

    Time frame: randomization though 30 days after percutaneous coronary intervention (PCI)

  2. Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

    Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin.

    Time frame: randomization though 30 days after percutaneous coronary intervention (PCI)

  3. Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE

    Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE. Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL. MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization

    Time frame: randomization though 30 days after percutaneous coronary intervention (PCI)

07

Results

Posted May 21, 2010

Participant flow

Participant flow — Overall Study
MilestonePrasugrel (CS-747) 40-mg LD/7.5 mg MDPrasugrel (CS-747) 60-mg LD/10-mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrel
Started200200251254
Completed187186236239
Not completed13141515
Withdrew: Adverse event5599
Withdrew: Death0030
Withdrew: Lost to follow-up1200
Withdrew: Withdrawal by subject4413
Withdrew: Protocol violation1010
Withdrew: Protocol entry criteria not met1102
Withdrew: Physician decision1211

Outcome measures

PrimaryNumber of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events

Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.

Time frame:
randomization though 30 days after percutaneous coronary intervention (PCI)
Reported as:
Number · participants
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
participantsPrasugrel (CS-747) 40-mg LD/7.5-mg MDPrasugrel (CS-747) 60-mg LD/10-mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelPrasugrel (CS-747) Combined
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events344311
Statistical analysis
  • Prasugrel (CS-747) 40-mg LD/7.5-mg MD vs Prasugrel (CS-747) 60-mg LD/10-mg MD vs Prasugrel (CS-747) 60-mg LD/15-mg MD · Fisher Exact · p = 0.933
  • Clopidogrel vs Prasugrel (CS-747) Combined · Log Rank · p = 0.590
SecondaryNumber of Participants With Major Adverse Cardiovascular Events (MACE)

Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.

Time frame:
randomization though 30 days after percutaneous coronary intervention (PCI)
Reported as:
Number · participants
Number of Participants With Major Adverse Cardiovascular Events (MACE)
participantsPrasugrel (CS-747) 40-mg LD/7.5-mg MDPrasugrel (CS-747) 60-mg LD/10-mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelPrasugrel (CS-747) Combined
Number of Participants With Major Adverse Cardiovascular Events (MACE)1515172447
Statistical analysis
  • Prasugrel (CS-747) 40-mg LD/7.5-mg MD vs Prasugrel (CS-747) 60-mg LD/10-mg MD vs Prasugrel (CS-747) 60-mg LD/15-mg MD · Fisher Exact · p = 0.945
  • Clopidogrel vs Prasugrel (CS-747) Combined · Log Rank · p = 0.260
SecondaryNumber of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin.

Time frame:
randomization though 30 days after percutaneous coronary intervention (PCI)
Reported as:
Number · participants
Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
participantsPrasugrel (CS-747) 40-mg LD/7.5-mg MDPrasugrel (CS-747) 60-mg LD/10-mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelPrasugrel (CS-747) Combined
Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding11123
Statistical analysis
  • Prasugrel (CS-747) 40-mg LD/7.5-mg MD vs Prasugrel (CS-747) 60-mg LD/10-mg MD vs Prasugrel (CS-747) 60-mg LD/15-mg MD · Fisher Exact · p = 1.0
  • Clopidogrel vs Prasugrel (CS-747) Combined · Log Rank · p = 0.544
SecondaryNumber of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE

Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE. Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL. MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization

Time frame:
randomization though 30 days after percutaneous coronary intervention (PCI)
Reported as:
Number · participants
Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE
participantsPrasugrel (CS-747) 40-mg LD/7.5-mg MDPrasugrel (CS-747) 60-mg LD/10-mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelPrasugrel (CS-747) Combined
Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE1719202756
Statistical analysis
  • Clopidogrel vs Prasugrel (CS-747) Combined · Fisher Exact · p = 0.370

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prasugrel (CS-747) 40-mg LD/7.5 mg MD—17/199 (8.5%)147/199 (73.9%)
Prasugrel (CS-747) 60-mg LD/10 mg MD—9/200 (4.5%)157/200 (78.5%)
Prasugrel (CS-747) 60-mg LD/15-mg MD—18/251 (7.2%)192/251 (76.5%)
Clopidogrel—22/254 (8.7%)195/254 (76.8%)
Most frequent serious events
Showing 10 of 45
Most frequent serious events
EventPrasugrel (CS-747) 40-mg LD/7.5 mg MDPrasugrel (CS-747) 60-mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrel
Chest painGeneral disorders6/1992/2006/2515/254
Myocardial infarctionCardiac disorders3/1991/2000/2511/254
Gastrointestinal haemorrhage nosGastrointestinal disorders0/1991/2003/2511/254
Catheter site haemorrhageGeneral disorders2/1990/2000/2511/254
Coronary artery dissectionCardiac disorders2/1990/2001/2510/254
Vascular pseudoaneurysmVascular disorders2/1990/2001/2510/254
Haematocrit decreasedInvestigations0/1990/2000/2512/254
HaematuriaRenal and urinary disorders0/1990/2000/2512/254
Hypotension nosVascular disorders0/1990/2000/2512/254
HypoxiaRespiratory, thoracic and mediastinal disorders0/1990/2000/2512/254
Most frequent other events
Showing 10 of 17
Most frequent other events
EventPrasugrel (CS-747) 40-mg LD/7.5 mg MDPrasugrel (CS-747) 60-mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrel
Catheter site haemorrhageGeneral disorders27/19935/20037/25130/254
Back painMusculoskeletal and connective tissue disorders11/19919/20028/25128/254
Chest painGeneral disorders15/19921/20012/25119/254
Catheter site ecchymosisGeneral disorders14/19915/20024/25112/254
NauseaGastrointestinal disorders18/19911/20023/25124/254
Angina pectorisCardiac disorders18/19911/20015/25123/254
ContusionSkin and subcutaneous tissue disorders9/19913/20020/25111/254
Hypotension nosVascular disorders14/19911/20013/25117/254
HeadacheNervous system disorders9/19912/20017/25115/254
Catheter site dischargeGeneral disorders8/19913/20011/2518/254

Baseline characteristics

Age, Customized
Age, Customized(participants)Prasugrel (CS-747) 40 mg LD/7.5 mg MDPrasugrel (CS-747) 60 mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelTotal
<=18 years00000
>18 and <= 65 years129152185195661
> 65 years70486659243
Age Continuous
Age Continuous(years)Prasugrel (CS-747) 40 mg LD/7.5 mg MDPrasugrel (CS-747) 60 mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelTotal
Mean60.4 ± 8.7258.7 ± 9.1559.4 ± 8.9758.4 ± 9.1759.2 ± 9.03
Sex: Female, Male
Sex: Female, Male(Participants)Prasugrel (CS-747) 40 mg LD/7.5 mg MDPrasugrel (CS-747) 60 mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelTotal
Female47495359208
Male152151198195696
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Prasugrel (CS-747) 40 mg LD/7.5 mg MDPrasugrel (CS-747) 60 mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelTotal
African descent101415948
Western Asian331310
Caucasian180180226238824
East/Southeast Asian11103
Hispanic527216
Other00123
Region of Enrollment
Region of Enrollment(participants)Prasugrel (CS-747) 40 mg LD/7.5 mg MDPrasugrel (CS-747) 60 mg LD/10 mg MDPrasugrel (CS-747) 60-mg LD/15-mg MDClopidogrelTotal
Canada43444846181
United States156156203208723
08

Study locations

2 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
    Boston, Massachusetts, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4599) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Victoria, British Columbia, Canada
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003, a primary completion of Jan 2004 and a completion of Jan 2004. It does not say whether these dates are actual or estimated.

Results were first posted in May 2010, 6 years 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2003
First posted
Apr 23, 2003
Start
Apr 2003
Primary completionActual
Jan 2004
CompletionActual
Jan 2004
Results first posted
May 21, 2010
Last update
May 25, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00059215
Lead sponsor
Eli Lilly and Company
First posted
Apr 23, 2003
Start date
Apr 2003
Primary completion
Jan 2004
Completion
Jan 2004
Results posted
May 21, 2010
Last update
May 25, 2010

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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