A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00097591
First received: November 24, 2004
Last updated: August 25, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Arteriosclerosis Acute Coronary Syndromes |
Drug: Prasugrel Drug: Clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 13619 |
| Study Start Date: | November 2004 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: Prasugrel
Administered orally
Other Names:
|
|
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
|
Drug: Clopidogrel
Administered orally
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097591
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097591
Locations
| United States, Indiana | |
| For more information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Global Quintiles Study Line (1-866-615-4672) or speak with your physician | |
| Indianapolis, Indiana, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Inc.
Investigators
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli LIlly |
| ClinicalTrials.gov Identifier: | NCT00097591 History of Changes |
| Other Study ID Numbers: | 8695, H7T-MC-TAAL |
| Study First Received: | November 24, 2004 |
| Results First Received: | April 19, 2010 |
| Last Updated: | August 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Arteriosclerosis Atherosclerosis Coronary Artery Disease Myocardial Ischemia Syndrome Angina Pectoris Arterial Occlusive Diseases Cardiovascular Diseases Chest Pain Coronary Disease Disease Heart Diseases Pain Pathologic Processes |
Signs and Symptoms Vascular Diseases Clopidogrel Prasugrel Ticlopidine Cardiovascular Agents Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Purinergic Agents |
ClinicalTrials.gov processed this record on February 26, 2015