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

• ClinicalTrials.gov Identifier: NCT02696226
• Recruitment Status: Terminated
• First Posted: March 2, 2016
• Results First Posted: November 8, 2017
• Last Update Posted: August 24, 2018
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Douglas Johnston, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aortic Valve Disorder	Drug: SAVR Warfarin; Drug: SAVR Aspirin; Drug: TAVR Warfarin and clopidogrel; Drug: TAVR Aspirin and clopidogrel	Not Applicable

Detailed Description:

This will be a pilot prospective randomized controlled trial.The study will enroll 50 adult patients scheduled to undergo SAVR and 50 adult patients scheduled to undergo TAVR. Subjects who satisfy Inclusion/Exclusion Criteria will be approached for informed consent. Those who give informed consent will be enrolled. After induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups.

1. SAVR patients will get either Warfarin or aspirin
2. TAVR patients will get either Warfarin or aspirin.

Patients will be seen at 4-6 weeks postoperatively for Transthoracic ECHO (TTE), 4 dimensional (4D), Multidetector computed tomography (MDCT) scan and review of medical history. Phone follow up at 6,9 and 12 months post-operatively.

Data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: July 28, 2017
• Actual Study Completion Date: July 28, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: SAVR Warfarin Arm; Warfarin arm-(target INR of 2-3)	Drug: SAVR Warfarin; 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; Other Name: Coumadiin
Experimental: TAVR Warfarin and Clopidogrel Arm; Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm	Drug: TAVR Warfarin and clopidogrel; 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; Other Names: Coumadin; Plavix
Experimental: SAVR Aspirin Arm; Aspirin arm (81mg/day)	Drug: SAVR Aspirin; 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.; Other Name: Aspirin
Experimental: TAVR Aspirin and Clopidogrel Arm; Aspirin (81mg/day) and Clopidogrel (75mg/day) arm	Drug: TAVR Aspirin and clopidogrel; 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; Other Name: Plavix

Outcome Measures

Primary Outcome Measures :

1. Leaflet Motion [ Time Frame: 4-6 weeks post procedure ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Scheduled for SAVR or TAVR

• Age > 18 years
• Able and willing to give informed consent
• Able and willing to return for follow up

Exclusion Criteria:

• 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).

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Douglas Johnston, M.D.; The Cleveland Clinic

  Study Documents (Full-Text)

Documents provided by Douglas Johnston, The Cleveland Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] May 5, 2016

More Information

• Responsible Party: Douglas Johnston, MD, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02696226
• Other Study ID Numbers: 16-084
• First Posted: March 2, 2016
• Results First Posted: November 8, 2017
• Last Update Posted: August 24, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Aspirin; Warfarin; Clopidogrel; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Anticoagulants