subjects undergoing elective cardiac catheterization with planned percutaneous coronary intervention (PCI) with coronary stenting. MedDRA version: 8.1 Level: LLT Classification code 10023031 Term: Ischemia coronary artery origin
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Subjects =18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia. [2] At least one of the following (a through c): a) Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following: 1. A reversible defect on nuclear imaging. 2. A reversible wall-motion abnormality by echocardiography. 3. Horizontal or down-sloping ST-depressions >1 mm on electrocardiogram (ECG) (if no imaging performed). b) Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)]. c) A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cardiovascular Exclusion Criteria [1] Known creatine kinase-myocardial bands (CK-MB) or cardiac troponin greater than the upper limit of normal (ULN) at the time of screening. [2] Have a planned PCI procedure as initial treatment for an acute myocardial infarction (MI) (STEMI or NSTEMI), or a planned PCI within 48 hours of fibrinolytic therapy for STEMI. [3] Have cardiogenic shock at the time of screening (systolic blood pressure 1.5 at the time of screening. [10] Have a platelet count of 2 weeks of daily treatment with NSAID or COX2 inhibitors during the study. General Exclusion Criteria [16] Are investigative site personnel directly affiliated with the study or are immediate family of investigative site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [17] Are employed by Eli Lilly & Company, Ube Industries Limited, Daiichi Sankyo Company Limited, The TIMI Study Group, or the contract research organization (CRO) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly sponsored clinical studies but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [18] Have received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indication at the time of study entry or are presently enrolled in another drug or device study. [19] Have previously completed or withdrawn from this study or any other study investigating prasugrel. [20] Are women who are known to be pregnant, who have given birth within the past 90 days, who are breastfeeding, or of child-bearing potential who test negative for pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To compare the inhibition of platelet aggregation (IPA) to 20 µM adenosine diphosphate (ADP) measured at 6 hours (±30 minutes) after prasugrel 60 mg loading dose (LD) versus clopidogrel 600 mg LD in subjects in the “on treatment population” who did not receive a GPIIb/IIIa inhibitor. -To compare the IPA to 20 µM ADP measured after 14±2 days of prasugrel 10 mg daily maintenance dose (MD) versus the IPA after 14±2 days of clopidogrel 150 mg daily MD in the “on treatment population” who have received PCI (this includes subjects receiving clopidogrel and prasugrel in either order during the crossover phase).;Secondary Objective: - To compare the inhibition of platelet aggregation (IPA) after Prasugrel(P) 60 mg loading dose (LD) versus clopidogrel(C) 600 mg LD in subjects in the “on treatment population” who did not receive a GPIIb/IIIa inhibitor. - To compare overall safety and tolerability of P 60 mg LD and 10 mg daily MD versus C 600 mg LD and 150 mg daily MD after 14±2 days in treated subjects who have received PCI. - To compare overall safety and tolerability of the following dosing regimens: P 60 mg LD and 10 mg daily MD for 14±2 days with crossover to C 150 mg daily MD for 14±2 days versus C 600 mg LD and 150 mg daily MD for 14±2 days with crossover to P 10 mg daily MD for 14±2 days in treated subjects who have received PCI. - To compare P versus C in the occurrence of Major Adverse Cardiac Events (MACE) after 14±2 days in treated subjects who have received PCI. - To compare P versus C on additional measures of platelet inhibition. - To compare P versus C in measures of myonecrosis following PCI.;Primary end point(s): -Inhibition of platelet aggregation (IPA) to 20 µM adenosine diphosphate (ADP) by light transmission aggregometry (LTA) at 6 hours (±30 minutes) after loading dose of study drug. IPA is defined as (1- [maximal platelet aggregation at time x after drug treatment]/[maximal platelet aggregation before drug treatment]) × 100. -IPA to 2 | — |
Countries
France, Germany
Outcome results
None listed