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Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Primary Purpose

Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin

Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aspirin group
Non-antithrombotic group
Sponsored by
OCEAN-SHD Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Keio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aspirin group

Non-antithrombotic group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2023
Last Updated
August 17, 2023
Sponsor
OCEAN-SHD Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT06007222
Brief Title
Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Official Title
Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OCEAN-SHD Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin, DAPT(Dual Antiplatelet Therapy), SAPT(Single Antiplatelet Therapy)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin group
Arm Type
Active Comparator
Arm Description
Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Arm Title
Non-antithrombotic group
Arm Type
Experimental
Arm Description
No antithrombotic agents will be administered after randomization until the end of the study period.
Intervention Type
Drug
Intervention Name(s)
Aspirin group
Intervention Description
Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Intervention Type
Drug
Intervention Name(s)
Non-antithrombotic group
Intervention Description
No antithrombotic agents will be administered after randomization until the end of the study period.
Primary Outcome Measure Information:
Title
Primary endpoint
Description
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.
Time Frame
minimum 1 year, maximum 3 years of follow-up
Secondary Outcome Measure Information:
Title
Key Secondary endpoint
Description
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.
Time Frame
minimum 1 year, maximum 3 years of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yosuke Sawa
Phone
07024924466
Email
sawa.yosuke872@eps.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosuke Sawa
Organizational Affiliation
EPS Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Keio University Hospital
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kentaro Hayashida
Phone
03-5843-6702
Email
khayashida.z6@keio.jp
First Name & Middle Initial & Last Name & Degree
Yuya Adachi
First Name & Middle Initial & Last Name & Degree
Tetsuro Shimura
First Name & Middle Initial & Last Name & Degree
Masanori Yamamoto
First Name & Middle Initial & Last Name & Degree
Minoru Tabata
First Name & Middle Initial & Last Name & Degree
Hiroshi Ueno
First Name & Middle Initial & Last Name & Degree
Hiroto Suzuyama
First Name & Middle Initial & Last Name & Degree
Masahiko Asami
First Name & Middle Initial & Last Name & Degree
Shinichi Shirai
First Name & Middle Initial & Last Name & Degree
Yusuke Watanabe
First Name & Middle Initial & Last Name & Degree
Masahiro Yamawaki
First Name & Middle Initial & Last Name & Degree
Norio Tada
First Name & Middle Initial & Last Name & Degree
Futoshi Yamanaka
First Name & Middle Initial & Last Name & Degree
Yohei Ohno
First Name & Middle Initial & Last Name & Degree
Masaki Izumo
First Name & Middle Initial & Last Name & Degree
Kazumasa Yamasaki
First Name & Middle Initial & Last Name & Degree
Hidetaka Nishina
First Name & Middle Initial & Last Name & Degree
Yasushi Fuku
First Name & Middle Initial & Last Name & Degree
Kazuki Mizutani
First Name & Middle Initial & Last Name & Degree
Fumiaki Yashima

12. IPD Sharing Statement

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Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

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