Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.

NCT02696226 | Terminated Results

• 1 other identifier: 16-084
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.

Conditions

Aortic Valve Disorder

Outcome Measures

Primary Outcomes (1)

• Leaflet Motion

  Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (\<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (\>70% reduction), or immobile (lack of motion of at least one valve leaflet).

  4-6 weeks post procedure

Study Arms (4)

SAVR Warfarin Arm

EXPERIMENTAL

Warfarin arm-(target INR of 2-3)

Drug: SAVR Warfarin

TAVR Warfarin and Clopidogrel Arm

EXPERIMENTAL

Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm

Drug: TAVR Warfarin and clopidogrel

SAVR Aspirin Arm

EXPERIMENTAL

Aspirin arm (81mg/day)

Drug: SAVR Aspirin

TAVR Aspirin and Clopidogrel Arm

EXPERIMENTAL

Aspirin (81mg/day) and Clopidogrel (75mg/day) arm

Drug: TAVR Aspirin and clopidogrel

Interventions

SAVR Warfarin DRUG

Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely

Also known as: Coumadiin

SAVR Warfarin Arm

SAVR Aspirin DRUG

Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.

Also known as: Aspirin

SAVR Aspirin Arm

TAVR Warfarin and clopidogrel DRUG

Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely

Also known as: Coumadin, Plavix

TAVR Warfarin and Clopidogrel Arm

TAVR Aspirin and clopidogrel DRUG

Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely

Also known as: Plavix

TAVR Aspirin and Clopidogrel Arm

Eligibility Criteria

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

You may qualify if:

• Scheduled for SAVR or TAVR
• Age \> 18 years
• Able and willing to give informed consent
• Able and willing to return for follow up

You may not qualify if:

• Contraindications to warfarin, Plavix or aspirin
• Pre-existing medical indication for warfarin, Plavix or aspirin
• History of previous cardiac surgery
• History of previous coronary artery stenting
• Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm
• Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR \< 60 ml/min).

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Aspirin; Clopidogrel; Warfarin

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Results Point of Contact

• Title: Dr. Douglas Johnston
• Organization: Cleveland Clinic

JOHNSTD3@ccf.org

216-444-5613

Study Officials

• Douglas Johnston, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 2, 2016
• Study Start: February 1, 2016
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: August 24, 2018
• Results First Posted: November 8, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)