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New treatment option for Aortic Stenosis
Official title Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
ClinicalTrials.gov ID: NCT06007222
What this study is testing
What is Aspirin group?
Aspirin group is an investigational medicine, being studied as a potential treatment for aortic stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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
You likely can't join if
- Those with perioperative complications at the time of TAVI (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac...
- Individuals requiring antiplatelet agents for reasons other than TAVI (history of myocardial infraction, history of PCI（Percutaneous Coronary...
- Patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other...
- 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.
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shinjuku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shinjuku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.