Overview

In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients

Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
0
Participant gender:
All
Summary
Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events, including stent thrombosis, in patients undergoing stent procedures who have not been pretreated with clopidogrel. In vitro investigations have shown cangrelor to be associated with more rapid, potent, and consistent platelet inhibition in patients on maintenance prasugrel therapy exposed to a re-loading dose of prasugrel. However, if cangrelor exerts similar effects in ticagrelor treated patients remain unknown. The aim of the present study is to evaluate the effects on platelet function achieved after in vitro incubation with cangrelor in patients on ticagrelor maintenance dose who receive a loading dose of ticagrelor.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Collaborator:
The Medicines Company
Treatments:
Adenosine
Cangrelor
Polystyrene sulfonic acid
Ticagrelor
Criteria
Inclusion criteria:

1. Patients with angiographically documented coronary artery disease.

2. Age between 18 to 80 years

3. On treatment per standard of care with ticagrelor 90mg/b.i.d. and aspirin <100mg/day
for at least 14 days.

Exclusion criteria

1. History of intracranial bleeding

2. Known severe hepatic dysfunction

3. Known hypersensitivy

4. Active bleeding or propensity to bleed

5. Platelet count <80x106/mL

6. Hemodynamic instability

7. Serum creatinine <30 mL/min

8. Use of oral anticoagulants (Vitamin K antagonist, dabigatran, rivaroxaban, apixaban)

9. Recent (<14 days) antiplatelet treatment with a glycoprotein IIb/IIIa inhibitor

10. Blood dyscrasia

11. Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker

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].