Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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)..

Key facts

Study ID: NCT01587651
Run by: Daiichi Sankyo
People needed: 110
Starts: 2012-03-01
Expected to finish: 2013-02-01
Last updated by the study team: 2019-01-09

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Univ. of Florida College Medicine — Jacksonville, Florida, United States
Clinical Pharmacology Unit of Miami — Miami, Florida, United States
Progressive Medical Research — Port Orange, Florida, United States
Sinai Center for Thrombosis Research — Baltimore, Maryland, United States
Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States
Black Hills Cardiovascular Research — Rapid City, South Dakota, United States
West Houston Area Clinical Trial Consultants — Houston, Texas, United States
Cardiology Center of Houston — Katy, Texas, United States
University Hospital of Wales — Heathpark, Cardiff, United Kingdom
Bristol Heart Institute — Bristol, United Kingdom
University Hospital Leicester — Leicester, United Kingdom
Southampton General Hospital — Southampton, United Kingdom
New Cross Hospital — Wolverhampton, United Kingdom

Full record on ClinicalTrials.gov

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