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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR BRILINTA

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Clinical Trials for Brilinta

Trial ID Title Status Sponsor Phase Summary
NCT01373411 Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery Completed University of British Columbia Phase 4 Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.
NCT01373411 Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery Completed Cardiology Research UBC Phase 4 Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.
NCT01587651 Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease Completed Eli Lilly and Company Phase 4 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)..
NCT01587651 Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease Completed Daiichi Sankyo Inc. Phase 4 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)..
NCT01643031 Effect of Modifying Anti-platelet Treatment to Ticagrelor in Patients With Diabetes and Low Response to Clopidogrel Unknown status Meir Medical Center Phase 4 In recent years numerous studies have shown that the response of patients to the anti-platelet drug clopidogrel is widely variable. Furthermore, patients who do not respond well to the drug ("resistant") have been shown to be at increased risk to develop cardiac events, including myocardial infarction and mortality. It thus seems reasonable to test the efficacy of the drug (by platelet function tests) and modify treatment accordingly. However, a large study that examined a strategy of routine testing of clopidogrel response in thousands of patients (GRAVITAS study) did not show any clinical benefit. This study was limited, however, by a very low event rate (2.3%), and by the strategy employed to treat patients with low response (increasing the clopidogrel dose), which is currently known to be ineffective in many patients with low response. To overcome these limitations the investigators plan to examine a high risk population - patients with diabetes planned to undergo coronary angiography - and to treat clopidogrel low responders by switching their treatment to the potent anti-platelet drug ticagrelor, which has been shown to overcome clopidogrel low response. The investigators hypothesize that patients with diabetes and low response to clopidogrel will benefit clinically from switching therapy to ticagrelor. The main endpoint of the study will be the risk of myocardial enzyme elevation following percutaneous coronary intervention (PCI); a marker which has been strongly associated with poor clinical outcome. The aim of the study is, therefore, to assess whether a strategy of monitoring platelet function during clopidogrel treatment in patients with diabetes undergoing PCI, and modifying treatment to ticagrelor in patients with low response, will be associated with reduced risk of myocardial enzyme release. The investigators plan to enroll patients with treated diabetes, planned to undergo coronary angiography. Patients with acute or recent myocardial infarction will be excluded. They will be tested for response to clopidogrel by the VerifyNow P2Y12 assay (either on chronic clopidogrel treatment or 12-24 hours after receiving 300 mg clopidogrel). Patients with low response to clopidogrel (≥ 208 PRU) will be randomized to either continued treatment with clopidogrel (75 mg/day), or switching of treatment to ticagrelor (90 mg twice a day) for 30 days (followed by continued clopidogrel therapy). The primary endpoint will be the rate of troponin of CK-MB (cardiac enzymes) measured 20-24 hours after the PCI. Secondary endpoints will be the occurrence of adverse clinical endpoints - myocardial infarction, need for urgent revascularization or mortality at 30 days. The investigators aim to enroll 100 patients in each study group (ticagrelor vs. continued clopidogrel). Assuming a clopidogrel low response rate of 40% among patients with diabetes, about 500 patients would have to be screened to identify 200 patients with low response.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Brilinta

Condition Name

Condition Name for Brilinta
Intervention Trials
Coronary Artery Disease 27
Acute Coronary Syndrome 13
Myocardial Infarction 6
Thrombosis 3
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Condition MeSH

Condition MeSH for Brilinta
Intervention Trials
Coronary Disease 30
Coronary Artery Disease 30
Myocardial Ischemia 28
Acute Coronary Syndrome 16
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Clinical Trial Locations for Brilinta

Trials by Country

Trials by Country for Brilinta
Location Trials
United States 113
China 24
Canada 11
Korea, Republic of 6
Spain 3
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Trials by US State

Trials by US State for Brilinta
Location Trials
Florida 17
Texas 8
New York 7
Ohio 6
Minnesota 5
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Clinical Trial Progress for Brilinta

Clinical Trial Phase

Clinical Trial Phase for Brilinta
Clinical Trial Phase Trials
Phase 4 44
Phase 3 6
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Brilinta
Clinical Trial Phase Trials
Recruiting 28
Completed 18
Not yet recruiting 10
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Clinical Trial Sponsors for Brilinta

Sponsor Name

Sponsor Name for Brilinta
Sponsor Trials
AstraZeneca 22
University of Florida 11
The First Affiliated Hospital with Nanjing Medical University 3
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Sponsor Type

Sponsor Type for Brilinta
Sponsor Trials
Other 81
Industry 33
U.S. Fed 1
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Serving hundreds of leading biopharmaceutical companies globally:

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Federal Trade Commission
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Merck
Mallinckrodt
Cerilliant
Deloitte
Argus Health
Boehringer Ingelheim

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