CompletedNot Applicable

Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor

United States82 participantsStarted 2014-03

Plain-language summary

Recently, two new oral P2Y12 antagonists have been approved for clinical use: prasugrel, a third generation thienopyridine, and ticagrelor, a first in class cyclopentyltriazolopyrimidine (CPTP). These agents have been shown to be associated with more potent platelet inhibitory effects compared with clopidogrel. In addition, both agents have shown to be superior to clopidogrel in preventing recurrent ischemic events in the setting of acute coronary syndromes (ACS). Understanding how to switch patients from prasugrel to ticagrelor is an unmet need of clinical interest. The proposed PD investigation will have a prospective, randomized, parallel design aimed to show that switching patients from prasugrel to ticagrelor provides similar levels of platelet inhibition.

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with known coronary artery disease who presented with and ACS and underwent PCI. * Age between 18 and 74 years old. * On therapy with low-dose aspirin (81 mg) and prasugrel 10 mg/daily for at least 14 days as per standard of care Exclusion criteria: * History of stroke, transient ischemic attack (TIA) or intracranial bleeding. * Known allergies to ticagrelor. * Weight \< 60 Kg * On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban). * Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days. * Blood dyscrasia or bleeding diathesis. * Platelet count \<80x106/mL. * Hemoglobin \<10 g/dL. * Active bleeding. * Hemodynamic instability. * Creatinine Clearance \<30 mL/minute. * Known severe hepatic dysfunction. * Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection. * Current treatment with drugs interfering with cytochrom P450 3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin. * Pregnant females.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay

Timeframe: 7 days

Trial details

NCT IDNCT02016170

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2016-08-22

View on ClinicalTrials.gov More Coronary Artery Disease trials