2024-520387-34-01招募中3 期
A multicentre randomised study on percutaneous stellate ganglion block as first line treatment in patients with electrical storm: the STAR 2 study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 13
- 主要终点
- proportion of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment
研究概览
简要总结
The primary objective of the STAR 2 study is to assess if the efficacy of PSGB, expressed as the number of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment, is superior to amiodarone, considered the standard of care.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years
- •More than 3 episodes of fast-VT/VF treated by the internal or external defibrillator in the 12 hours before randomization and at least one in the three hours before.
- •Fast-VT or FV requiring internal or external treatment
- •Any structural heart disease
- •Acute or choric coronary disease
排除标准
- •Brugada syndrome or early repolarization syndrome
- •Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to any of the excipients
- •Contraindications to amiodarone or other study drugs (e.g. QT interval prolongation or known Long-QT syndrome, sick sinus syndrome, without a pacemaker; second- or third- degree AV block, without a pacemaker, active hyperthyroidism, severe hypotension, porphyria, untreated pheochromocytoma)
- •Neck judged unfeasible for the procedure by the clinicians
- •Previous heart transplantation
- •Previous surgical sympathetic denervation
- •Previous ablation of the stellate ganglion block
- •Ongoing treatment with intravenous AAD drugs. Enrolment may be possible under certain circumstances (see Table 3 page 62-63) in case of recurrences after discontinuation
- •Refractory cardiac arrest
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drugs whichever is longer
- •Pregnancy or breastfeeding
结局指标
主要结局
proportion of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment
proportion of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment
次要结局
未报告次要终点
研究者
Simone Savastano
Scientific
Fondazione IRCCS Policlinico San Matteo
研究点 (13)
Loading locations...
相似试验
撤回
4 期
A multicentre randomised study on percutaneous stellate ganglion block as first-line treatment in patients with electrical storm: the STAR 2 study2024-520387-34-00Fondazione IRCCS Policlinico San Matteo180
招募中
3 期
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)NCT07391657AstraZeneca508
招募中
3 期
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma (SOLAIRIA-1)2025-521950-41-00Generate Biomedicines Inc.271
招募中
3 期
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma (SOLAIRIA-1)Severe uncontrolled asthma2025-524040-35-00Generate Biomedicines Inc.80
招募中
3 期
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)NCT07346859Biopharma Plasma LLC56