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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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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)..

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prasugrel Maintenance Dose

Prasugrel 10 mg QD MD

Group Type EXPERIMENTAL

Prasugrel Maintenance Dose

Intervention Type DRUG

10mg maintenance dose, given as one 10mg film coated tablet

Ticagrelor Maintenance Dose

Ticagrelor 90 mg twice-daily (BID) MD

Group Type ACTIVE_COMPARATOR

Ticagrelor Maintenance Dose

Intervention Type DRUG

one 90mg film coated tablet

Prasugrel Loading Dose

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Group Type EXPERIMENTAL

Prasugrel Loading Dose

Intervention Type DRUG

60mg given as six 10mg film coated tablets

Prasugrel Maintenance Dose

Intervention Type DRUG

10mg maintenance dose, given as one 10mg film coated tablet

Interventions

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Prasugrel Loading Dose

60mg given as six 10mg film coated tablets

Intervention Type DRUG

Prasugrel Maintenance Dose

10mg maintenance dose, given as one 10mg film coated tablet

Intervention Type DRUG

Ticagrelor Maintenance Dose

one 90mg film coated tablet

Intervention Type DRUG

Other Intervention Names

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Effient Effient Brilinta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No