Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event - Full Text View

Sponsor:	Eli Lilly and Company
Collaborator:	Daiichi Sankyo Inc.
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00356135

Purpose

This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

Condition	Intervention	Phase
Coronary Arteriosclerosis Acute Coronary Syndrome	Drug: prasugrel Drug: clopidogrel Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus Clopidogrel in Subjects With Acute Coronary Syndrome Who Are Receiving Clopidogrel

Resource links provided by NLM:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To compare the pharmacodynamic effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose, as assessed by difference in mean MPA to 20 micromolar ADP approximately [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the pharmacodynamic effects (using MPA to 5 and 20 micromolar ADP) of a prasugrel 10-mg maintenance dose or prasugrel 60-mg loading dose/10-mg maintenance dose compared with a clopidogrel 75-mg maintenance dose [ Time Frame: baseline, 2 hours, 24 hours, 1 week, 2 weeks ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of switching subjects from clopidogrel to prasugrel [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
To evaluate variability in MPA to 20 micromolar ADP while taking clopidogrel in subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event [ Time Frame: over entire study ] [ Designated as safety issue: No ]
Pharmacodynamic effects on residual aggregation measured 6 minutes after the addition of 5 and 20 micromolar ADP of a prasugrel 10-mg maintenance dose or prasugrel 60-mg loading dose/10-mg maintenance dose to clopidrogel 75 mg maintenance dose [ Time Frame: baseline, 2 hours, 24 hours, 1 week, 2 weeks ] [ Designated as safety issue: No ]
To compare the Accumetrics Verify NowTM P2Y12 device with LTA for monitoring platelet aggregation when subjects are switched from maintenance-dose clopidogrel to maintenance-dose prasugrel [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment:	142
Study Start Date:	July 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Each arm has a 10-14 day run in therapy of maintenance dose 75 mg clopidogrel	Drug: prasugrel A: 60 mg loading dose day 1 then 10 mg maintenance dose, oral, daily, 14 days B: 10 mg, oral, daily 14 days Other: placebo oral, as blinding mechanism A: as day 1 maintenance dose B: as loading dose C: as loading dose
B: Experimental Each arm has a 10-14 day run in therapy of maintenance dose 75 mg clopidogrel	Drug: prasugrel A: 60 mg loading dose day 1 then 10 mg maintenance dose, oral, daily, 14 days B: 10 mg, oral, daily 14 days Other: placebo oral, as blinding mechanism A: as day 1 maintenance dose B: as loading dose C: as loading dose
C: Experimental Each arm has a 10-14 day run in therapy of maintenance dose 75 mg clopidogrel	Drug: clopidogrel 75 mg, oral, daily, 14 days Other: placebo oral, as blinding mechanism A: as day 1 maintenance dose B: as loading dose C: as loading dose

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel
Are of a legal age (and at least 18 years of age but no more than 75 years of age) and competent mental condition to provide written informed consent before entering the study

Exclusion Criteria:

Left main coronary artery stent or left anterior descending (LAD) bifurcation stent
Have any form of coronary revascularization (PCI or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit)
Have undergone CABG or PCI within 30 days of entry into the study
Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study
Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
Have any of the following:

history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA) have a body weight less than 60 kg

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356135

Locations

United States, Florida
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.
Jacksonville, Florida, United States, 32209
United States, Maryland
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.
Baltimore, Maryland, United States, 21215
United States, Massachusetts
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.
Worcester, Massachusetts, United States, 01655
United States, Michigan
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.
Ann Arbor, Michigan, United States, 48109
United States, Ohio
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.
Cincinnati, Ohio, United States, 45219
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.
Columbus, Ohio, United States, 43210
United States, Oklahoma
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.
Oklahoma City, Oklahoma, United States, 73104
United States, South Dakota
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.
Rapid City, South Dakota, United States, 57701
United States, Texas
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.
Houston, Texas, United States, 77024

Sponsors and Collaborators

Eli Lilly and Company

Daiichi Sankyo Inc.

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 am - 5 pm Eastern time (UTC/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:	10631, H7T-MC-TABM
Study First Received:	July 21, 2006
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00356135 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Disease
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions
Coronary Disease

Pathologic Processes
Therapeutic Uses
Syndrome
Clopidogrel
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 09, 2010