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Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Prasugrel (Drug); Clopidogrel (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the effects of this combination on platelet inhibition will provide guidance to physicians on the use of prasugrel in patients who have already been pretreated with clopidogrel.

Clinical Details

Official title: TRansferring From ClopIdogrel Loading Dose to Prasugrel Loading Dose in Acute Coronary Syndrome PatiEnTs: TRIPLET

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)

Secondary outcome:

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)

Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit

Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin

Percentage of Inhibition of Platelet Aggregation

Percentage of Poor Responders

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)

P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)

Eligibility

Minimum age: 18 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants hospitalized with acute coronary syndrome (ACS) [unstable angina (UA),

non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI)] as determined by the investigator, and who are anticipated to undergo percutaneous coronary intervention (PCI) as a treatment for the ACS event within 24 hours of the clopidogrel/placebo loading dose

- Participants provide signed informed consent form (ICF)

- Participants weigh at least 60 kilograms (kg) at the time of screening

- Women of child-bearing potential (that is, women who are not surgically or chemically

sterilized and who are between menarche and 1-year postmenopause), test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test Exclusion Criteria:

- Have cardiogenic shock at the time of randomization (systolic blood pressure greater

than 90 millimeters of mercury (mm Hg) associated with clinical evidence of end-organ hypoperfusion, or participants requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion

- Have refractory ventricular arrhythmias

- Have New York Heart Association (NYHA) Class IV congestive heart failure

- Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure

greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment

- Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to

randomization

- Have received nonfibrin-specific fibrinolytic therapy less than 48 hours prior to

randomization

- Have active internal bleeding or history of bleeding diathesis

- Have clinical findings, in the judgment of the investigator, associated with an

increased risk of bleeding

- Prior history of ischemic or hemorrhagic stroke

- Intracranial neoplasm, arteriovenous malformation, or aneurysm

- Prior history of transient ischemic attack (TIA)

- Have an International Normalized Ratio (INR) known to be greater than 1. 5 at the time

of evaluation

- Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of

evaluation

- Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of

evaluation

- Have received 1 or more doses of a thienopyridine (ticlopidine, clopidogrel, or

prasugrel) or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening

- Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7

days or planned use of a GPIIb/IIIa inhibitor during PCI

- Are receiving or will receive oral anticoagulation or other antiplatelet therapy,

other than aspirin (ASA), which cannot be safely discontinued for the duration of the study.

- Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or

cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical

trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

- Have previously completed or withdrawn from this study or any other study

investigating prasugrel

- Are women who are known to be pregnant, who have given birth within the past 90 days,

or who are breastfeeding

- Have a concomitant medical illness (for example, terminal malignancy) that in the

opinion of the investigator, is associated with reduced survival over the expected treatment period

- Have known severe hepatic dysfunction (that is, with cirrhosis or portal

hypertension)

- Have a history of intolerance or allergy to aspirin or approved thienopyridines

(ticlopidine, clopidogrel or prasugrel)

- May be unable to cooperate with protocol requirements and follow-up procedures

Locations and Contacts

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., Bangalore 560099, India

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., Hyderabaad 500 001, India

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., New Delhi 110 060, India

Additional Information

Starting date: May 2010
Last updated: November 15, 2012

Page last updated: August 23, 2015

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