NAPT trial

JRCT ID: jRCTs031220614

Registered date:07/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: aortic stenosis
• Date of first enrollment: 06/04/2023
• Target sample size: 400
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Composite endpoint consisting of all-cause deaths, myocardial infarction, stroke from any cause and bleeding from randomization to end of study (minimum 1 year, maximum 3 years of follow-up)

Secondary Outcome

Bleeding Events from Randomization to Study End.
Incidence of Overall Mortality from Randomization to Study End.
Incidence of Cardiovascular Death From Randomization to Study End.
Incidence of Acute Myocardial Infarction from Randomization to Study End.
Incidence of stroke from randomization to end of study.
Incidence of Transient Ischemic Attack from Randomization to Study End.
Incidence of systemic embolism excluding cerebral infarction from randomization to end of study.
Incidence of heart failure readmissions from randomization to study completion.
Incidence of Overall Readmissions From Randomization to Study End.
Trends in Aortic Valve Mean Pressure Gradient and Effective Orifice Area by Transthoracic Echocardiogram at 6 Months and 1 Year.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 (historty of myocardial infraction, history of PCI, history of EVT, hisotry 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 subinvestigator)
4) Patients with eGFR <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 subinvestigator judges the participation in the study inappropriate.

Related Information

• Primary Sponsor: Hayashida Kentaro
• Source(s) of Monetary Support: Edwards Lifesciences Corporation,MEDTRONIC JAPAN CO., LTD.