Aortic StenosisPhase 4NCT06007222
Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
A Phase 4 study testing Aspirin group and Non-antithrombotic group in people with Aortic Stenosis and TAVI(Transcatheter Aortic Valve Implantation), run by OCEAN-SHD Study Group at 1 site in Japan.
Trial summary
Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin
- What is being tested?
- Aspirin group and Non-antithrombotic group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- 6 Apr 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent transfemoral TAVI for aortic stenosis
- Patients aged 20 years or older at the time of informed consent
- Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study
Who cannot join
- Those with perioperative complications at the time of TAVI (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction/cerebral hemorrhage, new atrial fibrillation, new atrioventricular block)
- Individuals requiring antiplatelet agents for reasons other than TAVI (history of myocardial infraction, history of PCI（Percutaneous Coronary Intervention）, history of EVT（EndoVascular Treatment）, history of cerebral infraction and transient ischaemic stroke, with significant coronary artery narrowing, with high-grade carotid artery narrowing, and others judged as requiring antiplatelet therapy by the chief researcher or a sub-investigator)
- Patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other patients who are deemed to require anticoagulation therapy by the investigator or coinvestigator)
- Patients with eGFR（estimated Glomerular Filtration Rate） <30 and patients on hemodialysis/peritoneal dialysis.
- Patients with a history of valve replacement in the heart valves.
- Patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding.
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- Patients who have a concomitant medical illness associated with expected survival less than one year.
- Patients who have the contraindications for aspirin.
- Patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity.
- Patients requiring a legally acceptable representative, patients unable to obtain written informed consent, or patients unable to understand the outline or purpose of the study.
- Other patients for whom the principal investigator or the coinvestigator judges the participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Keio University Hospital
Shinjuku, Tokyo, 160-8582
Kentaro Hayashida, 03-5843-6702, khayashida.z6@keio.jp
Masanori Yamamoto
About this study
Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin, DAPT(Dual Antiplatelet Therapy), SAPT(Single Antiplatelet Therapy)
- Being tested
- Aspirin group, Non-antithrombotic group
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin groupDrug
Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Non-antithrombotic groupDrug
No antithrombotic agents will be administered after randomization until the end of the study period.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin group | Active comparator | Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. Receives: Drug: Aspirin group |
| Non-antithrombotic group | Experimental | No antithrombotic agents will be administered after randomization until the end of the study period. Receives: Drug: Non-antithrombotic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Composite endpoint consisting of all-cause deaths, myocardial infarction, stroke from any cause and bleeding from randomization to end of study
The outcomes of this study will comply with the Valve Academic Research Consortium 3 (VARC 3). VARC 3 Type 1, Type 2, Type 3, and Type 4 bleeding are all included as bleeding. In this study, the study subjects will be randomized after it has been confirmed that there were no perioperative complications, so it is essentially assumed that there will be no procedure-related bleeding.
Surviving subjects for whom the event does not occur will be censored as of the date the study treatment is discontinued or as of the last confirmed date of survival.
Measured: minimum 2 years, maximum 3 years of follow-up
Secondary outcomes (1)
Key Secondary endpoint
Bleeding Events from Randomization to Study End. Cardiovascular adverse events from randomization until the end of the study (composite endpoint comprised of cardiovascular death, myocardial infarction, or CVA).
The definition of censoring for survival time analysis is the same as that used for the primary endpoint.
Measured: minimum 1 year, maximum 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start6 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OCEAN-SHD Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yosuke Sawa, Study director, EPS Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007222
- Sponsor's protocol ID
- NAPT trial
- Status last verified
- Sep 2024
- First submitted
- 8 Aug 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
- ClinicalTrials.gov ID
- NCT06007222
- Acronym / sponsor ID
- NAPT trial
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin, DAPT(Dual Antiplatelet Therapy), SAPT(Single Antiplatelet Therapy)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- OCEAN-SHD Study GroupUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin group | Active comparator | Drug: Aspirin groupAspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. |
| Non-antithrombotic group | Experimental | Drug: Non-antithrombotic groupNo antithrombotic agents will be administered after randomization until the end of the study period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent transfemoral TAVI for aortic stenosis
- Patients aged 20 years or older at the time of informed consent
- Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study
Key exclusion criteria (11 listed)
- Those with perioperative complications at the time of TAVI (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction/cerebral hemorrhage, new atrial fibrillation, new atrioventricular block)
- Individuals requiring antiplatelet agents for reasons other than TAVI (history of myocardial infraction, history of PCI（Percutaneous Coronary Intervention）, history of EVT（EndoVascular Treatment）, history of cerebral infraction and transient ischaemic stroke, with significant coronary artery narrowing, with high-grade carotid artery narrowing, and others judged as requiring antiplatelet therapy by the chief researcher or a sub-investigator)
- Patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other patients who are deemed to require anticoagulation therapy by the investigator or coinvestigator)
- Patients with eGFR（estimated Glomerular Filtration Rate） <30 and patients on hemodialysis/peritoneal dialysis.
- Patients with a history of valve replacement in the heart valves.
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 |
|---|---|---|
| Aspirin groupAspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. | Drug | Aspirin group |
| Non-antithrombotic groupNo antithrombotic agents will be administered after randomization until the end of the study period. | Drug | Non-antithrombotic group |
Primary outcome
Primary endpoint
Time frame: minimum 2 years, maximum 3 years of follow-up
Composite endpoint consisting of all-cause deaths, myocardial infarction, stroke from any cause and bleeding from randomization to end of study The outcomes of this study will comply with the Valve Academic Research Consortium 3 (VARC 3). VARC 3 Type 1, Type 2, Type 3, and Type 4 bleeding are all included as bleeding. In this study, the study subjects will be randomized after it has been confirmed that there were no perioperative complications, so it is essentially assumed that there will be no procedure-related bleeding. Surviving subjects for whom the event does not occur will be censored as of the date the study treatment is discontinued or as of the last confirmed date of survival.
1 secondary outcome
Key Secondary endpoint
Time frame: minimum 1 year, maximum 3 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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.
Yosuke Sawa study director
EPS Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin group and Non-antithrombotic group in people with Aortic Stenosis and TAVI(Transcatheter Aortic Valve Implantation), run by OCEAN-SHD Study Group at 1 site in Japan.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Sep 2024. 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yosuke Sawa (+81-70-2492-4466, sawa.yosuke872@eps.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: minimum 2 years, maximum 3 years of follow-up). 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 23 Sep 2024.