Phase 4
Completed N=60
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)
Source: ClinicalTrials.gov NCT02486367 ↗Enrolled (actual)
60
Serious AEs
31.7%
Results posted
Jul 2022
Primary outcomePrimary: Platelet Reactivity — 275.5; 251; 234; 128.5 Platelet Reactivity Units
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Reactivity |
275.5; 251; 234; 128.5; 208; 80 | — |
| SECONDARY Inflammatory Monocyte Proportion |
21.55103; 21.50033; 22.23356; 25.12275; 17.98342; 21.626 | — |
| SECONDARY Change in D-Dimer Levels as Measured by Blood Test |
1564.668; 1377.07; 2851.912; 2961.475; 2653.55; 2635.958 | — |
| SECONDARY Change in sCD14 as Measured by Blood Test. |
1638.721; 1712.943; 1713.16; 1896.489; 1765.934; 1958.013 | — |
| SECONDARY Change in IL-6 as Measured by Blood Test. |
4.761; 4.4; 43.127; 52.125; 7.603; 7.18502 | — |
| SECONDARY Change in IL-8 as Measured by Blood Test |
6.841063; 4.837371; 8.58; 7.558923; 4.98; 4.584426 | — |
| SECONDARY Change in Mono-CD62P as Measured by Blood Test |
1.675; 1.525; 0.75; 0.715; 0.69; 0.73 | — |
| SECONDARY Change in Mono-2b3a as Measured by Blood Test |
2.27; 1.45; 1.45; 0.93; 0.615; 1.23 | — |
Eligibility Criteria
Inclusion Criteria
- Valvular heart disease and a clinical indication for TAVR
- Age of 18 years or older
- Capable of informed consent
- Planned transfemoral TAVR
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02486367). 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.