Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

NCT06007222 | Recruiting Phase 4

• 1 other identifier: NAPT trial
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 2 years, maximum 3 years of follow-up

Secondary Outcomes (1)

• Key Secondary endpoint

  minimum 1 year, maximum 3 years of follow-up

Study Arms (2)

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.

Drug: Aspirin group

Non-antithrombotic group

EXPERIMENTAL

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

Drug: Non-antithrombotic group

Interventions

Aspirin group DRUG

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

Aspirin group

Non-antithrombotic group DRUG

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

Non-antithrombotic group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• OCEAN-SHD Study Group: lead

Study Sites (1)

Keio University Hospital

Shinjuku, Tokyo, 160-8582, Japan

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Yosuke Sawa

  EPS Corporation

  STUDY DIRECTOR

Central Study Contacts

Yosuke Sawa

CONTACT

+81-70-2492-4466; sawa.yosuke872@eps.co.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 23, 2023
• Study Start: April 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

JP (1)