N/A
N=60
Impact of Ticagrelor Re-load on Pharmacodynamic Profiles
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01731041 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP) — 17.87; 23.4 PRI%
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ticagrelor 180mg (Drug); Ticagrelor 90mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP) |
17.87; 23.4 | — |
| SECONDARY P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12 |
16.8; 31.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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].
Data sourced from ClinicalTrials.gov (NCT01731041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.