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

Use our guide to learn which trials are right for you!

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
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Baltimore, Maryland 21215
2297
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Cincinnati, Ohio 45212
1882
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Heath Park, Cardiff
?
mi
from 91732
Heath Park,
Click here to add this to my saved trials
Jacksonville, Florida 32209
2130
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Katy, Texas 77450
1331
mi
from 91732
Katy, TX
Click here to add this to my saved trials
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Port Orange, Florida 32127
2194
mi
from 91732
Port Orange, FL
Click here to add this to my saved trials
Rapid City, South Dakota 57701
1049
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials