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Recruiting

NCT Number: NCT06007222

Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

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.

Recruiting

Interested in participating?

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keio University Hospital

Shinjuku, Tokyo, 160-8582, Japan

Location status: Recruiting

Location contact

Fumiaki Yashima

CONTACT

Futoshi Yamanaka

CONTACT

Gaku Nakazawa

CONTACT

Hidetaka Nishina

CONTACT

Hiroshi Ueno

CONTACT

Hiroto Suzuyama

CONTACT

Kazumasa Yamasaki

CONTACT

Kentaro Hayashida

CONTACT

[email protected]

03-5843-6702

Kouhei Yamaguchi

CONTACT

Masahiko Asami

CONTACT

Masahiko Noguchi

CONTACT

Masaki Izumo

CONTACT

Masanori Yamamoto

CONTACT

Norio Tada

CONTACT

Shinichi Shirai

CONTACT

Takahiro Tokuda

CONTACT

Tetsuro Shimura

CONTACT

Yasushi Fuku

CONTACT

Yohei Ohno

CONTACT

Yusuke Watanabe

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

  • 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.

Treatment and study plan

Aspirin group

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

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Key Secondary endpoint

    Time frame: minimum 1 year, maximum 3 years of follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yosuke Sawa

CONTACT

[email protected]

+81-70-2492-4466

Sponsors and collaborators

Lead sponsor

OCEAN-SHD Study Group

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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