Clinical trial • Phase IV • Cardiology

Rivaroxaban for Patent foramen ovale | Atrial septal defect

Phase IV trial of Rivaroxaban for Patent foramen ovale | Atrial septal defect.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Patent foramen ovale | Atrial septal defect
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
08-08-2024
First CTIS Authorization Date
15-08-2024

Trial design

Comparator arms: Acetylsalicylic acid (aspirin) dispersible tablet, max daily dose 100 mg (oral); Plavix (clopidogrel) 75 mg film-coated tablets, max daily dose 150 mg (oral). Schedule not specified in source.-controlled Phase IV trial in Netherlands.

Comparator
Comparator arms: Acetylsalicylic acid (aspirin) dispersible tablet, max daily dose 100 mg (oral); Plavix (clopidogrel) 75 mg film-coated tablets, max daily dose 150 mg (oral). Schedule not specified in source.
Target Sample Size
52
Trial Duration For Participant
611

Eligibility

Recruits 52 No vulnerable population selected. Inclusion requires: 'The subject is able to understand and is willing to provide written informed consent to participate in the trial'. Participants must provide written informed consent; minimum age is 18 years..

Pregnancy Exclusion
Pregnant or planning to become pregnant during the time of the study
Vulnerable Population
No vulnerable population selected. Inclusion requires: 'The subject is able to understand and is willing to provide written informed consent to participate in the trial'. Participants must provide written informed consent; minimum age is 18 years.

Inclusion criteria

  • {"criterion_text":"- The subject is aged 18 years or older - The subject is scheduled for percutaneous closure of a PFO or ASD as indicated by the treating physician - The subject is able to understand and is willing to provide written informed consent to participate in the trial"}

Exclusion criteria

  • {"criterion_text":"- Unable or unwilling to return for required follow-up visits\n- High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical\n- Mechanical heart valves or valvular disease requiring surgery or interventional procedure\n- Ongoing major bleeding or complicated or recent (<72 hours) major surgery\n- Severe thrombocytopenia (<50.000/ml)\n- Mitral valve regurgitation grade 3 or more\n- Aortic valve stenosis (AVA<1.0cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more\n- Left ventricular ejection fraction <30%\n- Life expectancy of less than 1 year\n- Any indication for long-term oral anticoagulation other than presence/closure of a PFO/ASD (such as atrial fibrillation)\n- Any indication for long-term (dual) antiplatelet therapy other than presence/closure of a PFO/ASD (such as recent coronary stenting)\n- Contraindication for the use of rivaroxaban or DAPT (e.g. history of intracranial bleeding) in the investigator's opinion\n- Pregnant or planning to become pregnant during the time of the study\n- Estimated glomerular filtration rate <50 ml/min/1.73m2\n- Use of medication that significantly interacts with rivaroxaban; medication that inhibits cytochrome P450 3A4 or P-glycoprotein (such as ketoconazole, human immunodeficiency virus (HIV) protease inhibitors, clarithromycin, erythromycin and fluconazole) or induces cytochrome P450 3A4 (such as rifampicin and several anti-epileptic drugs)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex)\n- Platelet activation (e.g. P-selectin, CD40 ligand)\n- Von Willebrand Factor Antigen (VWF Ag)\n- Beta-thrombglobulin (beta-TG)\n- Plasminogen activator inhibitor-1 (PAI-1)\n- D-dimer\n- Thrombin Generation Test\n- Anti Xa activity","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
52
Recruitment Window Months
20
Consent Approach
Written informed consent required from each participant. Inclusion criterion states: 'The subject is able to understand and is willing to provide written informed consent to participate in the trial'. Minimum age for consent is 18 years. Languages of consent documents not specified in the available source.

Geography

Total Number Of Sites
1
Total Number Of Participants
52

Netherlands

Latest Decision Or Authorization Date
15-08-2024
Number Of Sites
1
Number Of Participants
52

Sites

Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Cardiology
Contact Person Name
Lucas Boersma

Sponsor

Primary sponsor

Full Name
Sint Antonius Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Xarelto 20 mg film-coated tablets
Active Substance
Rivaroxaban
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
EU/1/08/472/037
Starting Dose
20 mg
Maximum Dose
20 mg
Investigational Product Name
Plavix 75 mg film-coated tablets
Active Substance
Clopidogrel
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
EU/1/98/069/001
Starting Dose
75 mg
Maximum Dose
150 mg
Investigational Product Name
ACETYLSALICYLIC ACID
Active Substance
Acetylsalicylic acid (aspirin); caffeine citrate listed as product substance
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
-
Starting Dose
100 mg
Maximum Dose
100 mg
Combination Treatment
Yes

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