A study to compare rivaroxaban, following successful TAVR, to an antiplatelet drug and determine if it is superior in reducing death or first thromboembolic events (DTE) and non-inferior towards primary bleeding events (PBE).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1644

Inclusion Criteria

• Man or woman of 18 years of age or older
• Have a successful TAVR of a native aortic valve stenosis

• Via iliofemoral or subclavian access
• With any approved/marketed TAVR device
• Provide written IC

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1368

Exclusion Criteria

1. Any atrial fibrillation (AF), at the time of randomization or previous, with an ongoing indication for oral anticoagulant treatment
2. Any other indication for continued treatment with any oral anticoagulant (OAC)

3. Known bleeding diathesis, such as but not limited to:
a. active internal bleeding, clinically significant bleeding, bleeding at a non-compressible site, or bleeding diathesis,
b. platelet count = 50,000/mm3 at screening
c. Hemoglobin level < 8.5 g/dL
d. history of intracranial hemorrhage or subdural hematoma
e. major surgery, biopsy of a parenchymal organ, or serious trauma within 30 days before randomization
f. active peptic ulcer or known upper GI bleeding within the last 3 months
4. Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation)
5. Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel or rivaroxaban or hypersensitivity to contrast media that could not be solved neither by switching to an alternate contrast media nor with pre-treatment with appropriate medication
6. Routine use of oral non-steroidal anti-inflammatory drugs (NSAID)
7. Concomitant therapy with systemic drugs that are strong inhibitors of both CYP 3A4 and P-gp (azole antimycotics such as ketoconazole and itraconazole or HIV protease inhibitors such as ritonavir)

8. Concomitant therapy with drugs that are strong CYP 3A4 inducers
(e.g. carbamazepine, phenytoin, rifampin, St. John's wort)
9. Concomitant therapy with omeprazole or esomeprazole that cannot be switched to an alternate medication.
Concomitant conditions
10. Planned coronary or vascular intervention or major surgery
11. Clinically overt stroke within the last 3 months
12. Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
13. Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
14. Active infective endocarditis
15. Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm (e.g., cervical cancer in situ that has been successfully treated)

16. Dementia or forgetfulness hindering compliance with medication intake or other study procedures
17. Legally incompetent to provide IC
18. Previous (30 days before enrolment) or concomitant participation in another clinical study with investigational medicinal product(s).
19. Previous assignment to treatment during this study
20. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) or sponsor
21. Female of childbearing potential
a. Who are not surgically sterile, or who are sexually active and not willing to use adequate contraceptive measures with a failure rate less than 1% per year (e.g. oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study, or
b. For whom a negative pregnancy test is unavailable before study entry, or
c. Who are pregnant or breast feeding before study entry.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 12/10/2018

A study to compare rivaroxaban, following successful TAVR, to an antiplatelet drug and determine if it is superior in reducing death or first thromboembolic events (DTE) and non-inferior towards primary bleeding events (PBE).

Recruitment & Eligibility

Study & Design

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