Aortic Valve Disorder
Conditions
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.
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
Interventions
DRUGSAVR 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
DRUGSAVR 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.
DRUGTAVR 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
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
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leaflet Motion | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SAVR Warfarin Arm Warfarin arm-(target INR of 2-3)
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 | 1 |
| TAVR Warfarin and Clopidogrel Arm Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm
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 | 0 |
| SAVR Aspirin Arm Aspirin arm (81mg/day)
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. | 2 |
| TAVR Aspirin and Clopidogrel Arm Aspirin (81mg/day) and Clopidogrel (75mg/day) arm
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 | 0 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Study terminated - lack of enrollment | 1 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | SAVR Warfarin Arm | TAVR Warfarin and Clopidogrel Arm | SAVR Aspirin Arm | TAVR Aspirin and Clopidogrel Arm | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 2 | 0 / 0 |
Outcome results
Primary
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).
Time frame: 4-6 weeks post procedure
Population: Study terminated