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 the primary bleeding events (PBE).
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]MedDRA version: 19.1 Level: PT Classification code 10002916 Term: Aortic valve replacement System Organ Class: 10042613 - Surgical and medical proceduresPatients with severe aortic stenosis that require Transcatheter aortic valve replacement are at risk of thrombus formation. Rivaroxaban (oral-anticoagulant) may reduce this risk, without increasing bleeding risk
- Registration Number
- EUCTR2015-001975-30-DK
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1520
Potential subjects must satisfy the following criteria to be enrolled in the study:
• Man or woman of 18 years of age or older
• Have a successful TAVR of a native aortic valve stenosis (either native of valve-in-valve)
• Via iliofemoral or subclavian access
• With any approved/marketed TAVR device
• Provide written IC
Successful TAVR (29) is defined:
1. Correct positioning of a single prosthetic heart valve into the proper anatomical location.
2. Intended performance of the prosthetic heart valve - presence of all 3 conditions post-TAVR:
a. mean aortic valve gradient < 20 mmHg
b. peak transvalvular velocity (aortic valve maximum velocity) < 3.0 m/s
c. no severe or moderate aortic valve regurgitation
3. Absence of periprocedural complications, such as:
a. Any type of periprocedural stroke
b. VARC graded life-threatening bleeding
c. Acute coronary artery obstruction requiring intervention
d. Major vascular complication requiring intervention (including access-site vascular complications, any new ipsilateral peripheral ischemia, distal embolization from a vascular source, aortic dissection, aortic rupture, ventricular perforation, cardiac tamponade, and annulus rupture)
e. Unresolved acute valve thrombosis
f. Any requirement of a repeat procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
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
Subjects are NOT eligible to participate in this trial if they meet ANY of the following exclusion criteria:
GENERAL
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)
BLEEDING RISKS OR SYSTEMIC CONDITIONS
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
CONCOMITANT AND STUDY MEDICATION
4. Any ongoing absolute indication for dual-antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure
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 or non-active prostate cancer)
OTHER EXCLUSION CRITERIA
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 investigat
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