subjects with acute coronary syndrome MedDRA version: 8.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Present with acute coronary syndrome (ACS) based on the disease diagnostic criteria and have planned treatment, as part of standard of care, with a one-time 900-mg loading dose of commercially available clopidogrel. [2] Are of a legal age (and at least 18 years of age to less than 85 years of age) and competent mental condition to provide written informed consent before entering the study. Informed consent must be signed by the study participant or authorized representative, according to local rules and regulations. 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 [4] Have overt ST-segment elevation myocardial infarction (STEMI). [5] Have cardiogenic shock (systolic blood pressure 1.5. [15] Have a platelet count of <100,000/mm3. [16] Have anemia (hemoglobin [Hgb] <10 gm/dL). Prior/Concomitant Therapy Exclusion Criteria [17] Have received any GPIIb/IIIa inhibitors less than 30 days prior to study entry or anytime during the study. [18] Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin, low molecular weight heparin, or hirudin) that cannot be safely discontinued for the duration of the study. [19] Are currently receiving chemotherapy or radiation therapy. General Exclusion Criteria [20] Are investigator site personnel directly affiliated with the study or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [21] Are employed by Eli Lilly & Company, Daiichi Sankyo, Inc., 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. [22] Have received treatment within the last 30 days with a drug 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. [23] Have previously completed or withdrawn from this study or any other study investigating prasugrel. [24] 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 at Visit 1 , but refuse to use a reliable method of birth control (that is barrier, hormonal, or abstinence) during the study. [25] Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival over the next 15 months. [26] Have any other condition, chronic illness, or medication that, in the opinion of the investigator, would preclude participation in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to establish superiority of a prasugrel 10-mg daily maintenance dose compared with a clopidogrel 150-mg daily maintenance dose;Secondary Objective: *To assess and compare a prasugrel 10-mg daily maintenance dose(MD) with a clopidogrel 150-mg daily MD as assessed by: - mean MPA to 5 µM ADP at the end of two 14-day treatment periods in subjects with ACS - mean IPA to 5 and 20 µM ADP at the end of two 14-day treatment periods in subjects with ACS *To compare the pharmacodynamic effect, as assessed by the phosphorylation status of VASP expressed as the mean [PRI] *To assess and compare the levels of ADP-induced P2Y12 reaction units *To assess and compare the levels of ADP-induced MPA *To compare a prasugrel 10-mg daily MD with a clopidogrel 150-mg daily MD *To estimate the effect on platelet aggregation of changing from a clopidogrel 900-mg loading dose to the initial MD *To explore the safety and tolerability of the daily MD of prasugrel versus clopidogrel *To explore the safety of prasugrel MD initiated after a clopidogrel 900-mg loading dose ;Primary end point(s): platelet aggregation response to adenosine diphosphate (ADP) | — |
Countries
France
Outcome results
None listed