Phase 4
N=80
Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02287909 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Platelet Reactivity Unit — 177; 164; 174; 26 PRU — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clopidogrel (Drug); Ticagrelor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Reactivity Unit |
177; 164; 174; 26 | >0.05 |
Summary
The recommended antiplatelet treatment regimen for patients affected by acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the combination of aspirin and a P2Y12 receptor inhibitor. More potent P2Y12 receptor inhibitors, such as ticagrelor, have been developed which are associated with less response variability than clopidogrel and better clinical outcomes. Ticagrelor use has increased significantly because of its more expanded Food and Drug Administration (FDA) indications compared with prasugrel. However, despite the evidence for sustained efficacy and safety, many physicians limit treatment duration with ticagrelor to the early phases following an ACS mostly due to cost issues and concerns about increased bleeding. Therefore, it is very common in clinical practice to switch patients while on maintenance dosing (MD) with ticagrelor to treatment with clopidogrel. However, the pharmacodynamic (PD) effects of switching from ticagrelor to clopidogrel remain unknown. Therefore, the aim of this investigation is to evaluate the PD effects of switching from ticagrelor to clopidogrel.
Eligibility Criteria
Inclusion Criteria
- Patients with angiographically documented CAD
- On therapy with aspirin( 2.5 times the upper limit of normal)
- Active bleeding or propensity to bleed or blood dycrasia
- Platelet count <80x106/mL
- Hemoglobin <10g/dL
- Hemodynamic instability
- Estimated glomerular filtration rate (eGFR) <30 mL/min
- On treatment with oral anticoagulants
- Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker protection
- Drugs interfering CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
- 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 (NCT02287909). 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.