Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Not authorised
Participants planned
180
Countries
1
Sites
13
electrical storm
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.
Key facts
- Sponsor
- Fondazione IRCCS Policlinico San Matteo
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-11-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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.
Conditions and MedDRA coding
electrical storm
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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
- CPVT
Exclusion criteria 11
- Brugada syndrome or early repolarization syndrome
- 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
- Active enrollment in another pharmacological study
- Pregnancy
- Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to other anesthetics allowed in the study
- Other contraindications to amiodarone administration (e.g. QT prolongation, LQT syndrome, severe bradycardia, second or third degree atrio-ventricular block)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Lidocaina Kabi 20 mg/ml soluzione iniettabile
PRD7411948 · Product
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PARAVERTEBRAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 046867014
- MA holder
- FRESENIUS KABI ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BUPISEN 5 mg/ml soluzione iniettabile
PRD776592 · Product
- Active substance
- Bupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PARAVERTEBRAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- 034171076
- MA holder
- INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L..
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Amiodarone Hikma 50 mg/ml soluzione iniettabile
PRD738881 · Product
- Active substance
- Amiodarone Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01BD01 — AMIODARONE
- Marketing authorisation
- 038320014
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione IRCCS Policlinico San Matteo
- Sponsor organisation
- Fondazione IRCCS Policlinico San Matteo
- Address
- Viale Camillo Golgi 19
- City
- Pavia
- Postcode
- 27100
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione IRCCS Policlinico San Matteo
- Contact name
- Simone Savastano
Public contact point
- Organisation
- Fondazione IRCCS Policlinico San Matteo
- Contact name
- Simone Savastano
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Not authorised | 180 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliera di Padova
U.O.C. Cardiologia, Via Nicolo' Giustiniani 2, 35128, Padova
Ospedale San Raffaele S.r.l.
Unità Operativa di Aritmologia ed Elettrofisiologia Cardiaca, Via Olgettina 60, 20132, Milan
Policlinico San Donato S.p.A.
Unità di Cardiologia Clinica, Interventistica e di Terapia Intensiva Coronarica (UTIC), Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Ospedaliera Di Perugia
S.C. Cardiologia, Piazzale Giorgio Menghini 9, 06129, Perugia
Azienda Unita Sanitaria Locale Di Bologna
UOC Cardiologia, Largo Bartolo Nigrisoli 2, 40133, Bologna
Centro Cardiologico Monzino S.p.A.
Ventricular Intensive Care (VIC) Uni, Via Carlo Parea 4, 20138, Milan
Fondazione IRCCS Policlinico San Matteo
S.C. Cardiologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
S.C. Cardiologia, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. Cardiologia, Corso Bramante 88, 10126, Turin
Azienda Unita Sanitaria Locale Umbria 1
Reparto di Cardiologia-UTIC, Via Guerriero Guerra 21, 06127, Perugia
ARNAS G. Brotzu
SC Cardiologia e UTIC, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda USL Toscana Centro
S.O.S. Cardiologia e Elettrofisiologia SMN, Piazza Di Santa Maria Nuova 1, 50122, Florence
ASST Grande Ospedale Metropolitano Niguarda
S.C. Cardiologia 1 Emodinamica, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-520387-34-00-for pubblication | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements-for publication | 1 |
| Subject information and informed consent form (for publication) | L1_GP letter-for publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF adults-for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS adults_Centers-for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS adults_Sponsor-for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS incapacitated subjects_Centers-for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS incapacitated subjects_Sponsor-for publication | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Amiodarone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Bupivacaine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Lidocaine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITA 2024-520387-34-00-for pubblication | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-04 | Italy | Acceptable with conditions 2025-11-21
|
2025-11-25 |