Aortic Valve DisorderNCT02696226
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
A study testing SAVR Warfarin, SAVR Aspirin and TAVR Warfarin and clopidogrel in people with Aortic Valve Disorder, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disorder
- What is being tested?
- SAVR Warfarin, SAVR Aspirin and TAVR Warfarin and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 28 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for SAVR or TAVR
- Age > 18 years
- Able and willing to give informed consent
- Able and willing to return for follow up
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial
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.
Read the 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.
- SAVR patients will get either Warfarin or aspirin
- 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
- Conditions
- Aortic Valve Disorder
- Being tested
- SAVR Warfarin, SAVR Aspirin, TAVR Warfarin and clopidogrel, TAVR Aspirin and clopidogrel
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAVR WarfarinDrug
Also called Coumadiin
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
SAVR AspirinDrug
Also called 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.
TAVR Warfarin and clopidogrelDrug
Also called Coumadin, Plavix
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
TAVR Aspirin and clopidogrelDrug
Also called Plavix
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
| Study group | Role | What they receive |
|---|---|---|
| SAVR Warfarin Arm | Experimental | Warfarin arm-(target INR of 2-3) Receives: Drug: SAVR Warfarin |
| TAVR Warfarin and Clopidogrel Arm | Experimental | Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm Receives: Drug: TAVR Warfarin and clopidogrel |
| SAVR Aspirin Arm | Experimental | Aspirin arm (81mg/day) Receives: Drug: SAVR Aspirin |
| TAVR Aspirin and Clopidogrel Arm | Experimental | Aspirin (81mg/day) and Clopidogrel (75mg/day) arm Receives: Drug: TAVR Aspirin and clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4-6 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve DisorderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Johnston, The Cleveland Clinic
- Investigators
- Douglas Johnston, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696226
- Sponsor's protocol ID
- 16-084
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2016
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02696226
- Acronym / sponsor ID
- 16-084
- Conditions
- Aortic Valve Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 8 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- SAVR patients will get either Warfarin or aspirin
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAVR Warfarin Arm | Experimental | Drug: SAVR WarfarinWarfarin arm-(target INR of 2-3) |
| TAVR Warfarin and Clopidogrel Arm | Experimental | Drug: TAVR Warfarin and clopidogrelWarfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm |
| SAVR Aspirin Arm | Experimental | Drug: SAVR AspirinAspirin arm (81mg/day) |
| TAVR Aspirin and Clopidogrel Arm | Experimental | Drug: TAVR Aspirin and clopidogrelAspirin (81mg/day) and Clopidogrel (75mg/day) arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for SAVR or TAVR
- Age > 18 years
- Able and willing to give informed consent
- Able and willing to return for follow up
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAVR WarfarinAlso: CoumadiinWarfarin 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 | Drug | SAVR Warfarin Arm |
| SAVR AspirinAlso: AspirinAspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care. | Drug | SAVR Aspirin Arm |
| TAVR Warfarin and clopidogrelAlso: Coumadin, PlavixBegin 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 | Drug | TAVR Warfarin and Clopidogrel Arm |
| TAVR Aspirin and clopidogrelAlso: PlavixAspirin (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 | Drug | TAVR Aspirin and Clopidogrel Arm |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Johnston, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAVR Warfarin, SAVR Aspirin and TAVR Warfarin and clopidogrel in people with Aortic Valve Disorder, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leaflet Motion (time frame: 4-6 weeks post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.