N/A
Completed N=82
Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor
Source: ClinicalTrials.gov NCT02016170 ↗Enrolled (actual)
82
Serious AEs
1.2%
Results posted
Oct 2016
Primary outcomePrimary: Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay — 45; 63 PRU
Summary
Recently, two new oral P2Y12 antagonists have been approved for clinical use: prasugrel, a third generation thienopyridine, and ticagrelor, a first in class cyclopentyltriazolopyrimidine (CPTP). These agents have been shown to be associated with more potent platelet inhibitory effects compared with clopidogrel. In addition, both agents have shown to be superior to clopidogrel in preventing recurrent ischemic events in the setting of acute coronary syndromes (ACS). Understanding how to switch patients from prasugrel to ticagrelor is an unmet need of clinical interest. The proposed PD investigation will have a prospective, randomized, parallel design aimed to show that switching patients from prasugrel to ticagrelor provides similar levels of platelet inhibition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay |
45; 63 | — |
| SECONDARY Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP). |
25; 36 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with known coronary artery disease who presented with and ACS and underwent PCI.
- Age between 18 and 74 years old.
- On therapy with low-dose aspirin (81 mg) and prasugrel 10 mg/daily for at least 14 days as per standard of care
Exclusion criteria
- History of stroke, transient ischemic attack (TIA) or intracranial bleeding.
- Known allergies to ticagrelor.
- Weight < 60 Kg
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
- Blood dyscrasia or bleeding diathesis.
- Platelet count <80x106/mL.
- Hemoglobin <10 g/dL.
- Active bleeding.
- Hemodynamic instability.
- Creatinine Clearance <30 mL/minute.
- Known severe hepatic dysfunction.
- Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
- Current treatment with drugs interfering with cytochrom P450 3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
- Pregnant females.
Data sourced from ClinicalTrials.gov (NCT02016170). 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. Informational only — not medical advice.