A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Daiichi Sankyo Co., Ltd.
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00830960

Purpose

The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Prasugrel Drug: Clopidogrel	Phase III

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Platelet Inhibition Following Prasugrel or Clopidogrel Administration in Asian Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

ADP-induced P2Y12 receptor-mediated platelet aggregation (P2Y12 Reaction Units; PRU) using the Accumetrics VerifyNow P2Y12 assay. [ Time Frame: At 4 hours following loading dose administration and at 30 days during maintenance dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADP-induced P2Y12 receptor-mediated platelet aggregation (PRU) as measured by the Accumetrics VerifyNow P2Y12 assay [ Time Frame: 30 minutes, 2 hours, and 4 hours following loading dose (LD) administration, and at 30 days and 90 days on maintenance dose (MD) therapy ] [ Designated as safety issue: No ]
ADP-induced P2Y12 receptor-mediated platelet aggregation (% inhibition) as measured by the Accumetrics VerifyNow P2Y12 assay [ Time Frame: 30 minutes, 2 hours, and 4 hours following loading dose (LD) administration, and at 30 days and 90 days on maintenance dose (MD) therapy ] [ Designated as safety issue: No ]
Risk of Cardiovascular (CV) death, nonfatal myocardial infarction (MI), or non-fatal stroke [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Risk of CV death, nonfatal MI, or urgent target vessel revascularization [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Risk of CV death, nonfatal MI, nonfatal stroke, or recurrent myocardial ischemia requiring hospitalization [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Risk of CV death, nonfatal MI, nonfatal stroke, urgent target vessel revascularization, or recurrent myocardial ischemia requiring hospitalization [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Risk of CV death, nonfatal MI, nonfatal stroke, urgent target vessel revascularization, or recurrent myocardial ischemia requiring hospitalization (analyzed individually) [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Risk of definite or probable stent thrombosis per ARC (Academic Research Consortium) definition [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Risk of definite, probable, or possible stent thrombosis per ARC definition [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Risk of all-cause death, nonfatal MI, or nonfatal stroke [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Incidence of non-CABG (coronary artery bypass graft)related TIMI (Thrombolysis in Myocardial Infarction) Major or Minor bleeding. [ Time Frame: Randomization through end of study (90 days) ] [ Designated as safety issue: Yes ]
Incidence of non-CABG related TIMI Life-threatening (a subset of non-CABG-related TIMI Major bleeding), Major, Minor, and Minimal bleeding (analyzed individually). [ Time Frame: Randomization through end of study (90 days) ] [ Designated as safety issue: Yes ]
Incidence of CABG-related TIMI Major or Minor bleeding. [ Time Frame: Randomization through end of study (90 days) ] [ Designated as safety issue: Yes ]
Inpatient healthcare resource utilization [ Time Frame: Initial hospitalization, 30 days, 90 days ] [ Designated as safety issue: No ]
Genetic variation related to drug metabolism and transport [ Time Frame: Baseline (If sample is not collected at baseline, it may be collected at a later time during the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	715
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Prasugrel 1: Experimental Loading dose 60mg followed by maintenance dose 10 mg/day	Drug: Prasugrel PO, daily, 90 days
Prasugrel 2: Experimental Loading dose 30mg followed by maintenance dose 7.5 mg/day	Drug: Prasugrel PO, daily, 90 days
Prasugrel 3: Experimental Loading dose 30mg followed by maintenance dose 5 mg/day	Drug: Prasugrel PO, daily, 90 days
Clopidogrel: Active Comparator Loading dose 300mg followed by maintenance dose 75 mg/day	Drug: Clopidogrel PO, daily, 90 days

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 (ACS) and is to undergo a percutaneous coronary intervention (PCI)
A person who is of East or Southeast Asian descent
A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study
If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control

Exclusion Criteria:

A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure
A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)
A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
A person who has a severe liver disease, such as cirrhosis
A person who has a condition such as alcoholism, mental illness, or drug dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830960

Contacts

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

1-317-615-4559

Locations

China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Beijing, China, 100853
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Guang Zhou, China, 510080
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Nanjing, China, 210008
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Shanghai, China, 200001
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Shenyang, China, 110016
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Xi'An, China, 710061
Contact: Eli Lilly
Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Daejeon, Korea, Republic of, 301-721
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Suwon-City, Korea, Republic of, 442-721
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Kwang Ju, Korea, Republic of, 501-757
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Seongnam-Si, Korea, Republic of, 463-707
Contact: Eli Lilly
Singapore
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Singapore, Singapore
Contact: Eli Lilly
Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Niao Sung Hsiang, Taiwan, 833
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Taichung, Taiwan, 404
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Taichung City, Taiwan, 40201
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Taipei, Taiwan, 112
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Hualien, Taiwan, 970
Contact: Eli Lilly
Thailand
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Bangkok, Thailand, 10400
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Muang District, Thailand, 50200
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

Daiichi Sankyo Co., Ltd.

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11299, H7T-MC-TACE
Study First Received:	January 27, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00830960 History of Changes
Health Authority:	China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA); Taiwan: Department of Health; Thailand: Food and Drug Administration; Singapore: Health Sciences Authority

Study placed in the following topic categories:

Heart Diseases
Clopidogrel
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Platelet Aggregation Inhibitors
Ischemia

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 May 06, 2009