NCT00059215

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
905

participants targeted

Target at P75+ for phase_2 cardiovascular-diseases

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_2 cardiovascular-diseases

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

May 21, 2010

Completed
Last Updated

May 25, 2010

Status Verified

May 1, 2010

Enrollment Period

9 months

First QC Date

April 21, 2003

Results QC Date

April 19, 2010

Last Update Submit

May 21, 2010

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

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.

    randomization though 30 days after percutaneous coronary intervention (PCI)

Secondary Outcomes (3)

  • Number of Participants With Major Adverse Cardiovascular Events (MACE)

    randomization though 30 days after percutaneous coronary intervention (PCI)

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

    randomization though 30 days after percutaneous coronary intervention (PCI)

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

    randomization though 30 days after percutaneous coronary intervention (PCI)

Study Arms (4)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

Clopidogrel

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

Prasugrel (CS-747)DRUG

Administered orally

Also known as: Prasugrel, LY640315, Effient, Efient
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 MD
ClopidogrelDRUG

Administered orally

Clopidogrel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Location

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

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Interventions

Prasugrel HydrochlorideClopidogrel

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2003

First Posted

April 23, 2003

Study Start

April 1, 2003

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

May 25, 2010

Results First Posted

May 21, 2010

Record last verified: 2010-05

Locations

US(1)CA(1)