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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 74
Updated:1/11/2019
Start Date:March 2012
End Date:February 2013

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A Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents

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)..


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
We found this trial at
9
sites
Port Orange, Florida 32127
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Port Orange, FL
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Baltimore, Maryland 21215
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Baltimore, MD
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Cincinnati, Ohio 45212
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Cincinnati, OH
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Heath Park, Cardiff
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Heath Park,
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Houston, TX
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Jacksonville, Florida 32209
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Jacksonville, FL
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Katy, Texas 77450
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Katy, TX
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Miami, FL
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Rapid City, South Dakota 57701
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Rapid City, SD
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