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SHORT RUN AF "Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk"
EU CTIS ID: 2024-516374-29-00
What this study is testing
evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 65 years old
- Diagnosis of excessive supraventricular ectopy activity defined as: i) ≥ 1% PAC / 24 h or any atrial runs ≥ 20 PACs (shorter than 30 seconds) on a 24-hour Holter ECG monitoring (the indication for the Holter will be let at the discretion of the doctor according to international guidelines indication) ii) Or any atrial runs ≥ 20 PACs but shorter than 30 seconds on a 15-21 days Holter ECG monitoring
- High risk embolism defined by a CHA2DS2VASC score ≥ 3
- Written consent from patient
- Patients able to attend consultations and Cerebral MRI at baseline and 24 months at the participating centre.
- Ability to understand and comply with the study protocol
You likely can't join if
- According to the SmPC, any contraindication to Rivaroxaban (particularly patients with ongoing major bleeding, vascular complication, prior haemorrhagic stroke or over recent stroke) or one of its excipients.
- Requires long-term antiplatelet therapy other than aspirin (i.e., patient requires any platelet aggregation inhibitor in addition to study treatment, in particular, the combination of two platelet aggregation inhibitors)
- Ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
- Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin)
- Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Patient refuse the treatment with rivaroxaban or anticipated to have poor compliance on study drug treatment Unwilling to attend study follow-up visits
- Cancer or other life threatening conditions
See the full eligibility criteria
Who can join
- Patients ≥ 65 years old
- Diagnosis of excessive supraventricular ectopy activity defined as: i) ≥ 1% PAC / 24 h or any atrial runs ≥ 20 PACs (shorter than 30 seconds) on a 24-hour Holter ECG monitoring (the indication for the Holter will be let at the discretion of the doctor according to international guidelines indication) ii) Or any atrial runs ≥ 20 PACs but shorter than 30 seconds on a 15-21 days Holter ECG monitoring
- High risk embolism defined by a CHA2DS2VASC score ≥ 3
- Written consent from patient
- Patients able to attend consultations and Cerebral MRI at baseline and 24 months at the participating centre.
- Ability to understand and comply with the study protocol
- Affiliation of social security regime
What rules you out
- According to the SmPC, any contraindication to Rivaroxaban (particularly patients with ongoing major bleeding, vascular complication, prior haemorrhagic stroke or over recent stroke) or one of its excipients.
- Requires long-term antiplatelet therapy other than aspirin (i.e., patient requires any platelet aggregation inhibitor in addition to study treatment, in particular, the combination of two platelet aggregation inhibitors)
- Ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
- Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin)
- Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Patient refuse the treatment with rivaroxaban or anticipated to have poor compliance on study drug treatment Unwilling to attend study follow-up visits
- Cancer or other life threatening conditions
- Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
- Conditions associated with an increased risk of bleeding: a. Major surgery within the previous month b. Planned surgery or intervention within the next 3 months c. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding d. Gastrointestinal hemorrhage within the past year e. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days f. Hemorrhagic disorder or bleeding diathesis g. Need for anticoagulant treatment of disorders other than atrial fibrillation h. Fibrinolytic agents within 48 hours of study entry i. Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg) j. Recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years
- Severe renal impairment (estimated creatinine clearance <30 mL/min or less)
- Active infective endocarditis
- Active liver disease, including but not limited to, associated or not with coagulopathy and a clinically significant risk of bleeding, including cirrhotic patients with a Child Pugh class B or C score.
- Inability to perform cerebral MRI
- Persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range
- Known active hepatitis C (positive HCV RNA)
- Known active hepatitis B (HBs antigen +, anti HBc IgM +)
- Known active hepatitis A
- Anemia (hemoglobin level less than 110 g/L) or thrombocytopenia (platelet count less than 150 X 109/L)
- Patients who have received an investigational drug in the past 30 days
- Patients considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
- Patient with cardiac prosthetic devices : Reveal, pace-maker, automatic implantable defibrillator
- Participation in another interventional clinical trial
- Patient on AME (state medical aid)
- Life expectancy <24 months
- Persons under psychiatric care
- Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)
- Patients deprived of their liberty by a judicial or administrative decision
- History of major hemorrhage after taking Rivaroxaban
- Documented atrial fibrillation or any other indication for oral anticoagulation
- Patients with previous documented AF
- Valvular congenital heart disease
- Anticoagulant agents in the month prior to the inclusion visit
- Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery) or in the past 30 days
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.