NAPT trial (NAPT trial)

Active, not recruiting

• Conditions: aortic stenosis

• Registration Number: jRCTs031220614

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study Start: 2023-04-06
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 400

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 (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.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Composite endpoint	From randomization to end of study (minimum 1 year, maximum 3 years of follow-up)	Composite endpoint consisting of: - All-cause deaths; - Myocardial infarction; - Stroke from any cause; - Bleeding

Secondary Outcome Measures

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