pharmacodynamic evaluation of switching from ticagrelor to prasugrel in subjects with stable coronary artery disease

Conditions: Coronary Artery Disease

Summary: this is a phase 4, multicenter, open-label (blinded pharmacodynamic pd results), randomized, 3-arm, parallel-design study of subjects with stable coronary artery disease cad. this study will compare the pd effect of prasugrel 10 mg qd (once-daily) maintenance dose with ticagrelor 90 mg bid (twice daily) maintenance dose in subjects with stable cad who have previously received ticagrelor loading does (ld) and maintenance dose (md)..


Eligibility criteria:
inclusion criteria: * male or female; age \>= 18 and \< 75 years * weight \>= 60 kg * receiving low dose asa (75 mg to 150 mg daily) for at least 7 days at the time of visit 1 and able to continue the same regimen throughout the study * stable cad. cad is defined as any of the following: * history of a positive stress test * previous coronary revascularization including percutaneous coronary intervention (pci), stent, or coronary artery bypass graft (cabg) * angiographic demonstration of cad (at least 1 lesion \>= 50 percent) * presence of at least moderate plaque by computed tomography (ct) angiography * electron beam ct coronary artery calcification score \>= 100 agatston units * if female, may be enrolled if one of the following 3 criteria are met: * had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form (icf) * post-menopausal for at least 1 year * if of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy * able and willing to provide written informed consent before entering the study exclusion criteria: * have a defined need for adenosine diphosphate (adp)-receptor inhibitor therapy, such as any of the following (or any other condition that in the investigator's judgment would require such therapy): * within =\< 12 months of an acute coronary syndrome (acs) event (unstable angina \[ua\], non-st-elevation myocardial infarction \[nstemi\], or st-elevation myocardial infarction \[stemi\]) regardless of initial treatment (that is, invasive versus noninvasive) * subjects who underwent angioplasty within 12 months including bare-metal stent and/or a drug-eluting stent * had any stent placed in an unprotected left main coronary artery or in the last patent artery within the last 12 months * received thienopyridine therapy within 30 days of study entry * plan to undergo coronary revascularization at any time during the trial * presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (tia); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry) * history of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (av) block or bradycardic-related syncope) * history or evidence of congestive heart failure (new york heart association class iii or above =\< 6 months before screening * severe hepatic impairment * history of uric acid nephropathy * uncontrolled hypertension, or systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg at screening * severely impaired renal function (glomerular filtration rate \< 30 ml/minute) or on dialysis * at risk for bleeding * taking prohibited medications

Keywords: cad prasugrel ticagrelor antiplatelet thienopyridine p2y12 inhibitors