The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease

Inclusion Criteria

• Male or female subjects > or = 18 years and or = 60 kg;
• On aspirin therapy (81 mg to 325 mg daily) at the time of screening and able to maintain a consistent aspirin dosing regimen from the baseline visit through the final study visit;
• Subjects who do not have contraindications for a thienopyridine (ie, prasugrel, clopidogrel, or ticlopidine) and have a history of stable atherosclerosis represented by CAD, defined as any of the following:
• Chronic stable angina;
• Documented prior ACS event > or = 30 days before screening and not currently prescribed or currently on thienopyridine therapy;
• Previous coronary revascularization including percutaneous transluminal coronary angioplasty, stent, or coronary artery bypass graft;
• Coronary Artery Disease (> or = 40% obstruction) in at least one coronary vessel after angiography;
• Documented history of positive stress test; or
• High coronary artery calcium score (> or = 90th percentile for age and gender) determined by cardiac computed tomography scan;
• Current smokers who smoke > or = ½ pack per day of cigarettes with a NicAlert™ level of 6;
• Non-smokers with a NicAlert level of 0, 1, or 2;
• Female subjects who meet one of the following:
• Women of childbearing potential with a negative serum pregnancy test at screening, who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control during the study. Approved methods of birth control are intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. Abstinence, partner's use of condoms, partner's vasectomy, and hormonal contraceptives are NOT acceptable methods of contraception;
• Women who have been postmenopausal for at least 1 year or have had a hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation at least 6 months prior to signing the Informed Consent Form (ICF); and
• Subjects with a competent mental condition to provide written informed consent before entering the study.

Exclusion Criteria

• Subjects who received a bare metal stent and/or a drug-eluting stent within the last 12 months;
• Subjects who have had an angiogram 180 mmHg or diastolic blood pressure >110 mmHg) at either the time of screening or baseline assessment;
• Bleeding risk exclusion criteria:
• Any known contraindication to treatment with an anticoagulant or antiplatelet agent;
• Prior history or clinical suspicion of cerebral vascular malformations, intracranial tumor, transient ischemic attack, or stroke, or recent history (within 3 months) of head trauma;
• Prior history or presence of significant bleeding disorders (eg, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding);
• History (within the last 5 years) or presence of gastric ulcers. Previous history of duodenal ulcer is acceptable but must have been successfully surgically or medically treated with no further evidence of disease in the past 6 months (from screening);
• Prior history of abnormal bleeding tendency (ie, prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure);
• Known prior history or presence of thrombocytopenia (platelet count 500,000/mm3) or recent history (within 6 months) of hemoglobin 1.5 or activated partial thromboplastin time (aPTT) > upper limit of normal (ULN) of laboratory reference range at screening;
• History of major surgery, severe trauma, fracture, or organ biopsy within 3 months prior to enrollment;
• Prior/concomitant therapy exclusion criteria:
• Subjects taking prasugrel, clopidogrel, ticlopidine, cilostazol, dipyridamole, warfarin, heparin, direct thrombin inhibitors, or GPIIb/IIIa inhibitors or = 3 × ULN of laboratory reference range; or bilirubin > or = 2 × ULN of laboratory reference range at screening;
• Subjects who are unwilling to make themselves available for the duration of the study and who will not abide by the research unit policy and proced