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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696226
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 2, 2016
Results First Posted : November 8, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Douglas Johnston, The Cleveland Clinic

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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




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).



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696226


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Douglas Johnston, M.D. The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Douglas Johnston, The Cleveland Clinic:
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Responsible Party: Douglas Johnston, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02696226    
Other Study ID Numbers: 16-084
First Posted: March 2, 2016    Key Record Dates
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:
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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