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

NCT02486367 | Completed Phase 4 Results DMC

• 1 other identifier: UH IRB # 06-14-33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine whether high-potency ADP receptor blockade reduces measures of platelet activation in patients after TAVR.
2. 2.To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic inflammatory response observed after TAVR.

Conditions

Aortic Stenosis; Inflammation; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity

  Platelet reactivity will be measured and reported as platelet reactivity units (PRU) using the VerifyNow system.

  Day 0,1,7,&30

Secondary Outcomes (7)

• Inflammatory Monocyte Proportion

  Day 0,1,7&30

• Change in D-Dimer Levels as Measured by Blood Test

  Day 0,1,7,&30

• Change in sCD14 as Measured by Blood Test.

  Day 0,1,7,&30

• Change in IL-6 as Measured by Blood Test.

  Day 0,1,7,&30

• Change in IL-8 as Measured by Blood Test

  Day0,1,7,&30

Study Arms (2)

Standard care/clopidogrel

ACTIVE COMPARATOR

300mg load followed by 75mg daily.

Drug: Clopidogrel

Ticagrelor

EXPERIMENTAL

180mg load followed by 90mg twice daily for 30 days.

Drug: Ticagrelor

Interventions

Clopidogrel DRUG

Standard ADP receptor blockade

Standard care/clopidogrel

Ticagrelor DRUG

High potency ADP receptor blockade

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Inflammation; Thrombosis

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. David Zidar
• Organization: University Hospitals Cleveland Medical Center

daz21@case.edu

216-791-3800

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: July 1, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 20, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-06

Locations

US (1)