Stable Coronary Artery Disease MedDRA version: 14.1 Level: LLT Classification code 10013098 Term: Disease coronary artery System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Prasugrel hydrochloride
Product Code: Prasugrel
Pharmaceutical Form: Film-coated tablet
CAS Number: 389574-19-0
Current Sponsor code: CS-747 hydrochloride salt, LY640315
Other descriptiv
Sponsors
Daiichi Sankyo, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female; age = 18 and 100 Agatston units 5. If female, may be enrolled if One of the following 3 criteria are met: i. Had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form (ICF) ii. Post-menopausal for at least 1 year iii. 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 6. Able and willing to provide written informed consent before entering the study 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. 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): a. 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) b. Subjects who underwent angioplasty within 12 months including bare-metal stent and/or a drug-eluting stent c. Had any stent placed in an unprotected left main coronary artery or in the last patent artery within the last 12 months 2. Received thienopyridine therapy within 30 days of study entry 3. Plan to undergo coronary revascularization at any time during the trial 4. 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) 5. 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) 6. History or evidence of congestive heart failure (New York Heart Association Class III or above) 7. Severe hepatic impairment 8. History of uric acid nephropathy 9. Uncontrolled hypertension, or systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening 10. Severely impaired renal function (glomerular filtration rate < 30 mL/minute) or on dialysis 11. At risk for bleeding 12.Taking prohibited medications 13.Meets any of the general exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the pharmacodynamic (PD) effects, expressed as P2Y12 reaction units (PRU) by the VerifyNow P2Y12 assay, in subjects with stable coronary artery disease (CAD), treated with prasugrel 10 mg daily (QD) maintenance dose (MD) (Arms A + B) and in subjects treated with ticagrelor 90 mg twice daily (BID) MD (Arm C), after 7 days of randomized study treatment.;Secondary Objective: To compare the PD effects measured: *By the Vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects treated with prasugrel 10 mg QD MD (Arms A + B) and in subjects treated with ticagrelor 90 mg BID MD (Arm C) after 7 days of randomized treatment *Using the VerifyNow Assay device-reported and calculated percent inhibition in subjects treated on Arms A + B and in subjects treated on Arm C after 7 days of randomized treatment To compare the PD effects, in terms of PRU, VerifyNow Assay device-reported and calculated percent inhibition, and PRI, in subjects treated on: *Arm A (prasugrel 60 mg loading dose [LD] + 10 mg QD MD) and in subjects treated on Arm C (ticagrelor 90 mg BID MD), at all time points *Arm B (prasugrel 10 mg QD MD) vs. Arm C (ticagrelor 90 mg BID MD), at all time points ;Primary end point(s): PRU by VerifyNow P2Y12 assay for prasugrel 10 mg QD MD (Arm A + B) and ticagrelor 90 mg BID MD (Arm C) after 7 days of randomized treatment.;Timepoint(s) of evaluation of this end point: After 7 days of randomized treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PRI by the VASP assay 2, 4, 24, 48 hours, and 7 days after first randomized study treatment • PRU by the VerifyNow P2Y12 assay 2, 4, 24, and 48 hours after first randomized study treatment • VerifyNow assay device-reported and calculated percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment • Percentage of subjects with HPR, defined as a) = 208 PRU and b) = 230 PRU by the VerifyNow P2Y12 assay, and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment ;Timepoint(s) of evaluation of this end point: See above section E.5.2 | — |
Countries
United Kingdom, United States
Contacts
Public ContactMedical Research and Strategy
Daiichi Sankyo, Inc.
Outcome results
None listed