A Phase 2/3 interventional study of Rivaroxaban 10 mg qd and Rivaroxaban 15 mg qd in Atrial Fibrillation, Atrial Appendage and Hemorrhage, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Treatment
Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.
Data on antithrombotic therapy after Left Atrial Appendage Closure (LAAC) are scarce and no randomized evaluation has been performed to demonstrate what is the best antithrombotic strategy following LAAC. LAAC is classically associated with a 6-week period of anticoagulation with warfarin + aspirin followed by once daily clopidogrel (75 mg) + aspirin (81-325 mg) until the 6 months visit, then aspirin alone is continued indefinitely, as tested in patients without contraindication for anticoagulation in the pivotal Watchman trials. LAAC is mostly used in Europe as an alternative to warfarin anticoagulation when patients have a contraindication to or are unsuitable for warfarin anticoagulation. The classic regimen is not applicable and believed to be too risky in such frail patients. These patients usually receive a regimen of daily clopidogrel + aspirin followed by single antiplatelet therapy (most frequently used treatment). Some patients receive oral anticoagulation without aspirin, including NOAC anticoagulation. Rivaroxaban is a tempting strategy for anticoagulation following LAAC in atrial fibrillation (AF) patients. The dose needs first to be carefully evaluated the trial propose a dose ranging study in patients who have undergone successful LAAC.
The study will evaluate two different Rivaroxaban regimen (10 or 15 mg a day) in comparison to dual antiplatelet therapy (DAPT) (aspirin+clopidogrel : control arm representing standard of care) after successful LAAC. The aim is to investigate whether rivaroxaban could provide correct anticoagulation levels and adequately suppress coagulation activation after LAAC.
The patient will be enrolled after left atrial appendage closure before discharge. The randomization is 1/1/1 between the 3 groups : rivaroxaban 10mg a day, rivaroxaban 15 mg a day and aspirin 75mg + clopidogrel 75 mg a day. At 10 and 90 days, the patients will be sampled for biological assessment : Prothrombin fragments 1+2, Factor Xa inhibitory activity, Russel Viper venom enzyme assay, thrombin anti-thrombin (TAT) complex, D-Dimers, Prothrombin time (Neoplastin) and plasma von Willebrand factor (vWf) Ag level
After 90 days, the patient will end his/her participation in the trial. Clinical endpoints (death, MI, Stroke, TIA, systemic embolism, extracranial major bleeding or clinically relevant non major bleeding) at 90 days will be assessed by a clinical endpoint committee. Central echographic laboratory will review all 90 days transesophageal echocardiography (TEE) to detect the presence of thrombus or peri-device leak.
The study is open-label. Central laboratory, clinical endpoint committee and echographic core laboratory is blinded to randomization arm.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 105 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rivaroxaban 10 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM
Drug: Rivaroxaban 10 mg qd
Rivaroxaban 15 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM
Drug: Rivaroxaban 15 mg qd
Aspirin 75 mg, 1 a day Clopidogrel 75 mg, 1 tablet a day from randomization to Day 90 should be taken between 8 and 10 AM
Drug: DAPT
10mg qd
Also known as: Experimental
15mg qd
Also known as: Experimental
Aspirin 75 mg qd + Clopidogrel 75 mg qd
Also known as: Active comparator
Measure of prothrombin fragment 1 + 2
Measure of prothrombin fragment 1 + 2 at Day 10 (2 to 4 hours after last intake : concentration peak)
Time frame: at Day 10
Measure of prothrombin fragment 1 + 2
Measure of prothrombin fragment 1 + 2 at Day 90 (2 to 4 hours after last intake : concentration peak)
Time frame: at Day 90
Factor Xa inhibitory activity at day 10
Factor Xa inhibitory activity
Time frame: at Day 10
Factor Xa inhibitory activity at day 90
Factor Xa inhibitory activity
Time frame: at Day 90
Russel Viper venom enzyme assay
Russel Viper venom enzyme assay
Time frame: at Day 90
TAT complex
TAT complex
Time frame: at Day 10
TAT complex
TAT complex
Time frame: at Day 90
D-Dimers
D-Dimersand at peak, 2 to 4 hours after treatment intake
Time frame: at Day 10
D-Dimers
D-Dimersand at peak, 2 to 4 hours after treatment intake
Time frame: at Day 90
Prothrombin time (Neoplastin)
Prothrombin time (Neoplastin)
Time frame: at Day 10
Prothrombin time (Neoplastin)
Prothrombin time (Neoplastin)
Time frame: at Day 90
Plasma vWf Ag level
plasma vWf Ag level treatment intake
Time frame: at Day 10
Plasma vWf Ag level
plasma vWf Ag level treatment intake
Time frame: at Day 90
Haemorrhagic stroke and bleeding will be safety outcomes TEE with central core lab reading: presence of thrombus, peri-device leak
Haemorrhagic stroke and bleeding will be safety outcomes 3-month TEE with central core lab reading: presence of thrombus, peri-device leak
Time frame: at Day 90
Composite clinical endpoint combining all clinical outcomes
Composite clinical endpoint combining all clinical outcomes : Death, MI, stroke, TIA,
Time frame: at Day 90
Death (any cause)
Death (any cause) assessed individually and combined at other outcomes
Time frame: at Day 90
Myocardial infarction (MI)
Myocardial infarction (MI) assessed individually and combined at other outcomes
Time frame: at Day 90
Stroke (ischaemic stroke, haemorrhagic stroke)
Stroke (ischaemic stroke, haemorrhagic stroke) assessed individually and combined at other outcomes
Time frame: at Day 90
Transient Ischemic Attack (TIA)
Transient Ischemic Attack (TIA) assessed individually and combined at other outcomes
Time frame: at Day 90
Systemic embolism
Systemic embolism assessed individually and combined at other outcomes
Time frame: at Day 90
Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) at day 90
Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) assessed individually and combined at other outcomes
Time frame: at Day 90
Plan to share: No
Ran from Sep 2017 to primary completion in Nov 2018, 14 months.
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Studies of the drug tested here: Rivaroxaban
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