A study to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.

Phase 1

• Conditions: Patients with severe aortic stenosis that require Transcatheter aorticvalve replacement are at risk for stroke. This study is to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.; MedDRA version: 19.0Level: PTClassification code 10002916Term: Aortic valve replacementSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001777-33-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-06
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Potential patients must satisfy the following criteria to be enrolled in the study:
- Man or woman of 18 years of age or older, who are planned for TAVR
- TAVR of a native aortic valve stenosis
- By iliofemoral or subclavian access
- With any approved/marketed TAVR device
- EARTH Written informed consent

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 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 207

Exclusion Criteria

Patients are NOT eligible to participate in this study 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)
3. Any contraindication for cerebral MRI, in particular:
- non-MRI-conditional pacemakers
- MRI conditional pacemakers <4 weeks after implant
- any metal fragments in the eye
- aneurysm clip in the brain
- severe claustrophobia

Bleeding risks or systemic conditions
4. 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
5. Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months’ after TAVR (such as coronary, carotid or peripheral stent implantation)
6. 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
7. Routine use of oral non-steroidal anti-inflammatory drugs (NSAID)
8. Concomitant therapy with systemic drugs that are strong inhibitors of both CYP3A4 and P-gp (azole antimycotics such as ketoconazole and itraconazole or HIV protease inhibitors such as ritonavir)
9. Concomitant therapy with drugs that are strong CYP 3A4 inducers (e.g. carbamazepine, phenytoin, rifampin, St. John’s wort)
10. Concomitant therapy with omeprazole or esomeprazole that cannot be switched to an alternate medication.

Concomitant conditions
11. Planned coronary or vascular intervention or major surgery
12. Clinically overt stroke within the last 3 months
13. Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis before TAVR, or unresolved kidney injury with renal dysfunction stage 2 or higher
14. Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
15. Active infective endocarditis
16. Active malignancy (diagnosed within 5 years) except for adequately treated Nonmelanoma skin cancer or other non-invasive or in situ neoplasm (e.g.,cervical cancer in situ that has been successfully treated)

Other exclusion criteria
17. Dementia or forgetfulness hindering compliance with medication intake or other Study procedures
18. Legally incompetent to provide IC
19. Previous (30 days before enrolment) or concomitant participation in another clinical study with investigational medicinal product(s).
20. Previous assignment to treatment during this study
21. 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
22. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified