A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Daiichi Sankyo Co., Ltd. DCRI
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00699998

Purpose

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed UA/NSTEMI ACS population (that is, patients who are not managed with acute coronary revascularization).

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Clopidogrel Drug: Prasugrel Drug: Commercially-available Aspirin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Reduction in risk of the composite endpoint of first occurrence of CV death, MI, or stroke. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Risk of the composite endpoint of first occurence of CV death and MI. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ]
Risk of the composite endpoint of first occurrence CV death, MI, stroke, or re-hospitalization for recurrent UA. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ]
Risk of the composite endpoint of first occurrence of all-cause death, MI, or stroke. [ Time Frame: Randomization through end of study (minimum of 6-month follow-up period). ] [ Designated as safety issue: Yes ]
Platelet aggregation measures. [ Time Frame: Baseline and at various timepoints during study treatment. ] [ Designated as safety issue: No ]
Biomarker measurements of inflammation/hemodynamic stress. [ Time Frame: Baseline and at various timepoints during study treatment. ] [ Designated as safety issue: No ]
Genotyping related to drug metabolism. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Economic and Quality of Life Outcomes. [ Time Frame: Baseline, follow-up, and discontinuation from study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	10300
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Prasugrel and Low-dose Commercially-available Aspirin	Drug: Prasugrel 30mg, oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5mg or 10mg (based upon weight and age), oral, once daily as maintenance dose through end of study Drug: Commercially-available Aspirin Low-dose aspirin, oral, as prescribed by physician through end of study
2: Active Comparator Clopidogrel and Low-Dose Commercially-available Aspirin	Drug: Clopidogrel 300mg, oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75mg, oral, once daily as maintenance dose through end of study Drug: Commercially-available Aspirin Low-dose aspirin, oral, as prescribed by physician through end of study

Detailed Description:

Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TRILOGY ACS study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Have had a UA/NSTEMI index event within 10 days prior to randomization
Had a medical management strategy decision made with reasonable certainty that neither PCI nor CABG is planned for treatment of the index event
Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key Exclusion Criteria:

Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
Insignificant CAD on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
Previous or planned PCI or CABG as treatment for the index event
PCI/CABG within previous 30 days
STEMI as the index event
Cardiogenic shock, Refractory ventricular arrhythmias, NYHA Class IV CHF within the previous 24 hours
History of ischemic or hemorrhagic stroke, TIA, Intracranial neoplasm, arteriovenous malformation, or aneurysm
History of spontaneous GI or non-GI bleeding requiring hospitalization for treatment, unless definitive Rx has occurred and there is low likelihood of recurrence
Hemodialysis or peritoneal dialysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699998

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 561 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Daiichi Sankyo Co., Ltd.

DCRI

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11058, H7T-MC-TABY(b)
Study First Received:	June 16, 2008
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00699998 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

ACS

Study placed in the following topic categories:

Heart Diseases
Aspirin
Clopidogrel
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases

Angina Pectoris
Platelet Aggregation Inhibitors
Ischemia
Infarction
Angina, Unstable
Myocardial Infarction

Additional relevant MeSH terms:

Disease
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Pharmacologic Actions
Pathologic Processes

Syndrome
Clopidogrel
Therapeutic Uses
Acute Coronary Syndrome
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 28, 2009