Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Prasugrel Loading Dose; Prasugrel Maintenance Dose; Ticagrelor Maintenance Dose
Intervention description: 60mg given as six 10mg film coated tablets; 10mg maintenance dose, given as one 10mg film coated tablet; one 90mg film coated tablet
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: CAD; prasugrel; ticagrelor; antiplatelet; thienopyridine; P2Y12 Inhibitors

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