2024-516374-29-00招募中4 期
SHORT RUN AF. Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 11
- 主要终点
- The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Short Run Af
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
次要结局
- Efficacy-related endpoints: o A composite of ischemic stroke, peripheral embolism or major bleeding (net clinical benefit); a composite of death from cardiovascular causes, stroke, systemic embolism, myocardial infarction (major cardiovascular events); death from any cause; cognitive decline as assessed by the MMS (26). o Individual components of composite primary and secondary efficacy endpoints
- Exploratory endpoints: o Incidence of documented atrial fibrillation diagnosed from patient symptoms or systematic 24 hours ECG Holter performed at 1- and 2-year follow-up. o Incidence of asymptomatic MRI-detected cerebral damage including silent cerebral ischemia and microbleeds at 2-year follow up.
- Safety-related endpoints: o Life-threatening or fatal bleeding events, clinically relevant non-major bleeding intracranial hemorrhage and minor bleeding events. Bleeding severity will be assessed according to ISTH classification.
研究者
Pr Nicolas LELLOUCHE
Scientific
Assistance Publique Hopitaux De Paris
研究点 (11)
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