EUCTR2010-019791-73-GR进行中（未招募）不适用
A Randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors - Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •I 01. Patients in permanent atrial fibrillation defined by the presence of all of the following
- •Availability of one 12-lead ECG not more than 14 days prior to randomization,
- •showing that the patient is in atrial fibrillation or atrial flutter
- •Availability of documentation (including either rhythm strips or medical report of the
- •rhythm) showing that the patient was in atrial fibrillation or atrial flutter at least 6
- •months prior to randomization
- •No evidence of sinus rhythm in the period between these two documentations of atrial
- •fibrillation*
- •Patient and physician decision to allow atrial fibrillation to continue without further
- •efforts to restore sinus rhythm
- •I 02. Patients aged 65 years or older with at least one of the following risk criteria:
- •Coronary artery disease**
- •Prior stroke or TIA (confirmed by a neurologist)
- •Symptomatic heart failure***
- •Left ventricular ejection fraction less than or equal to 0.40
- •Peripheral arterial occlusive disease****
- •Aged 75 years or older with both hypertension and diabetes mellitus*****
- •I 03. Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •E 01. Patients in paroxysmal atrial fibrillation
- •E 02. Patients in persistent atrial fibrillation without a decision to allow atrial fibrillation to
- •continue without further efforts to restore sinus rhythm
- •E 03. Patients with atrioventricular node ablation or previously diagnosed with permanent thirddegree
- •E 04. Patients with an implanted cardiac defibrillator
- •E 05. Any noncardiovascular illness or disorder that could preclude participation or severely
- •limit survival, including cancer with metastasis and organ transplantation requiring
- •immune suppression
- •E 06. Previous (2 preceding months) or current participation in another clinical trial with an
- •investigational drug (under development) or with an investigational device
- •E 07. Previous participation in this trial
- •E 08. Dronedarone treatment within 3 months prior to randomization
- •E 09. Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, trial
- •coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •E 10. Patient likely noncompliant to the trial procedures
- •Exclusion criteria related to the current knowledge of dronedarone
- •E 11. Patients with heart failure of NYHA class IV or recent unstable* NYHA class III
- •Unstable*: intensification of heart failure therapy (eg, increased diuretics, ACE / ARBs, or
- •inotropes) due to increased symptoms within one month prior to randomization.
- •E 12. Sustained daytime bradycardia <50 bpm without a functioning electronic pacemaker
- •E 13. QTc interval >500 msec
- •E 14. Hypersensitivity to the active substance or to any of the excipients
- •E 15. Need for coadministration of strong CYP3A4 inhibitors, such as ketoconazole,
- •itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone and ritonavir leading
- •to systemic exposure
- •E 16. Need for coadministration of medicinal products inducing torsades de pointes such as
- •phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral
- •macrolides, or class I and III antiarrhythmics)
- •E 17. Severe hepatic impairment
- •E 18. Any additional contraindication according to local labeling of dronedarone (when available)
研究者
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