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Last Updated: October 24, 2020

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CLINICAL TRIALS PROFILE FOR TICAGRELOR

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505(b)(2) Clinical Trials for Ticagrelor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT02435563 Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling Active, not recruiting University Hospital, Geneva Phase 2 2014-08-01 Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ticagrelor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00391872 A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome Completed AstraZeneca Phase 3 2006-10-01 Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.
NCT00528411 A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin Completed AstraZeneca Phase 2 2007-10-01 The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.
NCT00642811 A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders Completed AstraZeneca Phase 2 2008-05-01 The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.
NCT01087723 European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial Completed The Medicines Company Phase 3 2010-03-01 To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.
NCT01118325 An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease Completed AstraZeneca Phase 2 2010-04-01 The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.
NCT01225562 Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin Completed AstraZeneca Phase 3 2010-10-01 This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ticagrelor

Condition Name

Condition Name for Ticagrelor
Intervention Trials
Coronary Artery Disease 74
Acute Coronary Syndrome 66
Myocardial Infarction 22
Healthy 11
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Condition MeSH

Condition MeSH for Ticagrelor
Intervention Trials
Acute Coronary Syndrome 93
Coronary Artery Disease 92
Coronary Disease 85
Myocardial Ischemia 84
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Clinical Trial Locations for Ticagrelor

Trials by Country

Trials by Country for Ticagrelor
Location Trials
United States 557
Canada 87
China 67
Japan 55
Italy 50
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Trials by US State

Trials by US State for Ticagrelor
Location Trials
Florida 41
Texas 24
New York 23
California 20
Maryland 19
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Clinical Trial Progress for Ticagrelor

Clinical Trial Phase

Clinical Trial Phase for Ticagrelor
Clinical Trial Phase Trials
Phase 4 184
Phase 3 59
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Ticagrelor
Clinical Trial Phase Trials
Recruiting 117
Completed 107
Not yet recruiting 61
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Clinical Trial Sponsors for Ticagrelor

Sponsor Name

Sponsor Name for Ticagrelor
Sponsor Trials
AstraZeneca 82
University of Florida 18
University of Patras 12
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Sponsor Type

Sponsor Type for Ticagrelor
Sponsor Trials
Other 381
Industry 119
NIH 2
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