Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Clopidogrel; Ticagrelor

Criteria

Inclusion Criteria:

1. Valvular heart disease and a clinical indication for TAVR

2. Age of 18 years or older

3. Capable of informed consent

4. Planned transfemoral TAVR

Exclusion Criteria:

1. Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage

2. Established bleeding diathesis or thrombocytopenia (<150k/dl)

3. End-stage renal disease

4. Severe hepatic impairment or liver cirrhosis

5. Pregnancy

6. Current infection

7. History of autoimmune disease

8. Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor

9. History of solid organ transplantation

10. Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation

11. Plan for direct aortic access or trans-apical TAVR

12. Enrollment in another clinical trial

13. Recent (< 12 months) or active excessive bleeding