Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)
Completed · Phase 4
Conditions studied: Aortic Stenosis, Inflammation, Thrombosis
In brief
The central hypothesis of this study is that TAVR leads to platelet deposition and inflammatory cell activation that can be attenuated by the potent anti-platelet and/or pleiotropic effects of ticagrelor. This single center, prospective randomized trial addresses the following specific aims: 1. To determine whether high-potency ADP receptor blockade reduces measures of platelet activation in patients after TAVR. 2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic inflammatory response observed after TAVR.
Key facts
- Study ID
- NCT02486367
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 60
- Starts
- 2015-06-01
- Expected to finish
- 2019-01-01
- Last updated by the study team
- 2022-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Valvular heart disease and a clinical indication for TAVR
- Age of 18 years or older
- Capable of informed consent
- Planned transfemoral TAVR
You may not qualify if…
- Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage
- Established bleeding diathesis or thrombocytopenia (<150k/dl)
- End-stage renal disease
- Severe hepatic impairment or liver cirrhosis
- Pregnancy
- Current infection
- History of autoimmune disease
- Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor
- History of solid organ transplantation
- Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation
- Plan for direct aortic access or trans-apical TAVR
- Enrollment in another clinical trial
- Recent (< 12 months) or active excessive bleeding
Where it is running
- UH Cleveland Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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