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A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

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ClinicalTrials.gov Identifier: NCT00097591
Recruitment Status : Completed
First Posted : November 25, 2004
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 24, 2004
First Posted Date  ICMJE November 25, 2004
Results First Submitted Date  ICMJE April 19, 2010
Results First Posted Date  ICMJE September 16, 2010
Last Update Posted Date September 16, 2010
Study Start Date  ICMJE November 2004
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke [ Time Frame: Randomization up to 15 months ]
The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00097591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events [ Time Frame: First dose of study drug up to 15 months (while at risk) ]
    TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: 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 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.
  • Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) [ Time Frame: Randomization to 30 days; randomization to 90 days ]
    The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.
  • Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke [ Time Frame: Randomization to 30 days; randomization to 90 days ]
    The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.
  • Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events [ Time Frame: Randomization up to 15 months ]
    The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.
  • Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke [ Time Frame: Randomization up to 15 months ]
    The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Official Title  ICMJE A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Brief Summary The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Arteriosclerosis
  • Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: Prasugrel
    Administered orally
    Other Names:
    • CS-747
    • LY640315
    • Effient
    • Efient
  • Drug: Clopidogrel
    Administered orally
Study Arms  ICMJE
  • Experimental: Prasugrel
    Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
    Intervention: Drug: Prasugrel
  • Active Comparator: Clopidogrel
    Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
    Intervention: Drug: Clopidogrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2010)
13619
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
  • A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
  • If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

  • A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
  • A person who has active internal bleeding or has a history of a bleeding disorder.
  • Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
  • A person who has liver disease; for example, cirrhosis.
  • A person who has a condition such as alcoholism, mental illness, or is drug dependent.
  • A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00097591
Other Study ID Numbers  ICMJE 8695
H7T-MC-TAAL ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli LIlly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Daiichi Sankyo, Inc.
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP