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Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease | Clinical Trials | Clareo Health

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

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

NCT01587651•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

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)..

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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
+5 more criteria

Locations (13)

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

Key Dates

Start Date

March 1, 2012

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

January 9, 2019

Enrollment

110

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

Prasugrel Loading Dose

DRUG

Prasugrel Maintenance Dose

DRUG

Ticagrelor Maintenance Dose

DRUG

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

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RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

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