Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Aortic Stenosis Clinical Trial

Official title:

Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007222
• Other study ID #: NAPT trial
• Status: Recruiting
• Phase: Phase 4
• Start date: April 6, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: OCEAN-SHD Study Group
• Contact: Yosuke Sawa
• Phone: 07024924466
• Email: sawa.yosuke872[@]eps.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients who underwent transfemoral TAVI for aortic stenosis

2. Patients aged 20 years or older at the time of informed consent

3. Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study

Exclusion Criteria:

1. 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)

2. 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)

3. 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)

4. Patients with eGFR(estimated Glomerular Filtration Rate) <30 and patients on hemodialysis/peritoneal dialysis.

5. Patients with a history of valve replacement in the heart valves.

6. Patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding.

7. Patients who have a concomitant medical illness associated with expected survival less than one year.

8. Patients who have the contraindications for aspirin.

9. Patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity.

10. 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.

11. Other patients for whom the principal investigator or the coinvestigator judges the participation in the study inappropriate.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Aspirin

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Keio University Hospital	Shinjuku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
OCEAN-SHD Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	minimum 1 year, maximum 3 years of follow-up
Secondary	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.	minimum 1 year, maximum 3 years of follow-up