Impact of Ticagrelor Re-load on Pharmacodynamic Profiles
Completed · Not applicable
Conditions studied: Coronary Artery Disease
In brief
Platelets are parts of your blood that stick together to help form a clot. The stickier your platelets are, the greater your chance of having a heart attack. A clot in the wrong place can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking together and it helps people from having a heart attack. The American College of Cardiology has recommended a combination of aspirin and Brilinta as one of the best treatments for the prevention of heart attacks, and death in patients who have had a heart attack or coronary stents. However, it is unknown if Brilinta may improve its work to keep platelets from sticking together giving a loading dose in patients already treated with Brilinta. A loading dose is a one-time increased dose of the same drug. The purpose of this study is to demonstrate whether the platelets of patients treated with Brilinta become less sticky when Brilinta is re-loaded.
Key facts
- Study ID
- NCT01731041
- Run by
- University of Florida
- People needed
- 60
- Starts
- 2013-01-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-06-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with a clinical indication to be on ticagrelor therapy (90mg/bid)
- On treatment with ticagrelor 90mg twice daily for at least 14 days
- Age between 18 to 80 years
- On aspirin <100mg/day
You may not qualify if…
- History of intracranial bleeding
- Severe hepatic impairment (ALT >2.5 times the upper limit of normal)
- Active bleeding or propensity to bleed
- Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist
- Platelet count <80x106/mL 7. Hemodynamic instability 8. Serum creatinine <30 mL/min 9. On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban) 10. Patients with sick sinus syndrome or II or III degree AV block without pacemaker protection 12. Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin 13. Hemoglobin < 10g/dL 14. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].
Where it is running
- University of Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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