Impact of Ticagrelor Re-load on Pharmacodynamic Profiles

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: AstraZeneca
• Treatments: Adenosine; Ticagrelor

Criteria

Inclusion Criteria:

1. Patients with a clinical indication to be on ticagrelor therapy (90mg/bid)

2. On treatment with ticagrelor 90mg twice daily for at least 14 days

3. Age between 18 to 80 years

4. On aspirin <100mg/day

Exclusion Criteria:

1. History of intracranial bleeding

2. Severe hepatic impairment (ALT >2.5 times the upper limit of normal)

3. Active bleeding or propensity to bleed

4. Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist

6. 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].