Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

NCT ID: NCT06007222

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Aortic Stenosis; TAVI(Transcatheter Aortic Valve Implantation); Aspirin; DAPT(Dual Antiplatelet Therapy); SAPT(Single Antiplatelet Therapy)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin group

Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.

Group Type: ACTIVE_COMPARATOR

Aspirin group

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Non-antithrombotic group

Intervention Type: DRUG

No antithrombotic agents will be administered after randomization until the end of the study period.

Interventions

Aspirin group

Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.

Intervention Type: DRUG

Non-antithrombotic group

No antithrombotic agents will be administered after randomization until the end of the study period.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OCEAN-SHD Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yosuke Sawa

Role: STUDY_DIRECTOR

EPS Corporation

Locations

Keio University Hospital

Shinjuku, Tokyo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yosuke Sawa

Role: CONTACT

sawa.yosuke872@eps.co.jp

+81-70-2492-4466

Facility Contacts

Kentaro Hayashida

Role: primary

khayashida.z6@keio.jp

03-5843-6702

Masanori Yamamoto

Role: backup

Tetsuro Shimura

Role: backup

Takahiro Tokuda

Role: backup

Masahiko Noguchi

Role: backup

Hiroshi Ueno

Role: backup

Hiroto Suzuyama

Role: backup

Masahiko Asami

Role: backup

Shinichi Shirai

Role: backup

Yusuke Watanabe

Role: backup

Kouhei Yamaguchi

Role: backup

Norio Tada

Role: backup

Futoshi Yamanaka

Role: backup

Yohei Ohno

Role: backup

Masaki Izumo

Role: backup

Kazumasa Yamasaki

Role: backup

Hidetaka Nishina

Role: backup

Yasushi Fuku

Role: backup

Gaku Nakazawa

Role: backup

Fumiaki Yashima

Role: backup

Other Identifiers

NAPT trial

Identifier Type: -

Identifier Source: org_study_id