EUCTR2010-023101-35-DK进行中（未招募）1 期
TUNDRA-AF: A mulTi-center, randomized, doUble-bliNded, placebo-controlled Dose-escalating study of the effects of K201 on the RestorAtion of sinus rhythm in subjects with symptomatic Atrial Fibrillation of recent onset - TUNDRA-AF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1. Able to provide written informed consent
- •2. Male or female 18 years of age or greater; women of child bearing potential must use adequate contraception: IUD or hormonal contraception (p-pill, implant, transdermal depot patch, vaginal ring or depot injection).
- •3. Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- •4. Atrial fibrillation documented by ECG at the start of study drug infusion.
- •5. Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.
- •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
- •1. Previous exposure to K201
- •2. Women who are pregnant or breast feeding. (Women of child bearing potential must have a negative pregnancy test prior to randomization.)
- •3. Systolic blood pressure <100 mmHg (unless documented to be usual value)
- •4. Heart rate <50 bpm documented by ECG
- •5. Temperature >38°C (oral or equivalent)
- •6. QTcF (Fridericia correction) >440 ms
- •7. QRS interval >140 ms
- •8. Paced atrial or paced ventricular rhythm on ECG
- •9. Serum potassium <3.5 meq/L (may be corrected prior to randomization)
- •10. History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- •11. History of amiodarone (oral or IV) in the last 3 months.
- •12. Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
- •13. Acute pulmonary edema
- •14. Acute pulmonary embolism
- •15. History of seizure (except febrile seizure)
- •16. History of alcohol abuse or drug/chemical addiction within the past 2 years.
- •17. Hyperthyroidism
- •18. Acute pericarditis
- •19. History of failed electrical cardioversion at any time in the past
- •20. History of polymorphic ventricular tachycardia (e.g. Torsades des pointes)
- •21. History or family history of Long QT Syndrome
- •22. History of ventricular tachycardia requiring drug or device therapy
- •23. History of administration of an investigational drug or device or participation in another investigational drug trial within 30 days before randomization
- •24. History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
- •25. Ejection fraction of 40% or less
- •26. Weight <40 kg or >200 kg
- •27. Any unrelated illness (e.g. active infection, inflammation, medical condition or laboratory abnormalities) which in the judgment of the investigator would significantly jeopardize patients' clinical status
- •28. Have received potent CYP2D6 or CYP3A inhibitors within 5 half-lives. Potent CYP2D6 include bupropion, fluoxetine, paroxetine, cinacalcet and quinidine. Potent CYP3A inhibitors include indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, ketoconazole, vorikonazole, posakonazole, and nefazodone
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