Rivaroxaban Monotherapy and CYP2C19 Genotype Testing in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

22 Aug 2024 → ongoing

Decision date (initial)

2024-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

This study will serve as a pilot to investigate the feasibility and safety of rivaroxaban monotherapy in 50 patients with atrial fibrillation after percutaneous coronary intervention.

Conditions and MedDRA coding

Coronary artery disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥18 years
2. Successful PCI
3. History of or newly diagnosed (<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC
4. Treatment with a loading dose of clopidogrel prior to or during PCI

Exclusion criteria 17

1. Known allergy or contraindication for rivaroxaban
2. Active bleeding on randomization
3. Severe anaemia requiring blood transfusion
4. Pregnancy or breast-feeding women
5. Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS
6. PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions
7. Participation in another trial with an investigational drug or device (i.e. stent
8. Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
9. Overwriting indication for DAPT (e.g. TIA/CVA or PAD)
10. Mechanical heart valve prosthesis
11. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
12. Intracardiac thrombus or apical aneurysm requiring OAC
13. Kidney failure (eGFR <15)
14. Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
15. Active malignancy excluding non-melanoma skin cancer
16. Suboptimal stenting result based on angiographic and optional intra-coronary imaging input
17. Systemic treatment with strong inhibitors or inducers of both cytochrome P450 (CYP) 3A4 and p-glycoproteine (P-gp; e.g. ketoconazole or carbamazepine)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary ischemic endpoints at 6 months is the composite of all-cause mortality, myocardial infarction (according to the 4th universal definition of MI), Academic Research Consortium (ARC) defined definite stent thrombosis, or ischemic stroke
2. The primary bleeding endpoint at 6 months is major bleeding or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

PhD-candidate

Public contact point

Organisation

Amsterdam UMC

Contact name

PhD-candidate

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications