VAsopressin and STeroids in addition to Adrenaline in cardiac arrest - a randomized clinical trial. VAST-A

2025-521283-35-00 Therapeutic confirmatory (Phase III) Temporarily halted

Start 2 Apr 2025 · Status Temporarily halted · 1 EU/EEA countries · 3 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Temporarily halted
Participants planned 1,400
Countries 1
Sites 3

Cardiac arrest

The primary objective of the study is to determine whether the use of a combination of adrenaline, vasopressin and steroids will increase 30 days survival in cardiac arrest patients compared to standard adrenaline alone

Key facts

Sponsor
Tiohundra AB
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
2 Apr 2025 → ongoing
Decision date (initial)
2025-04-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-521283-35-00
ClinicalTrials.gov
NCT05139849

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The primary objective of the study is to determine whether the use of a combination of adrenaline, vasopressin and steroids will increase 30 days survival in cardiac arrest patients compared to standard adrenaline alone

Secondary objectives 1

  1. Neurological outcome at 30 days (mRS and GOS-E) ROSC Survival at 6 months Neurological outcome (mRS and GOS-E) at 6 months

Conditions and MedDRA coding

Cardiac arrest

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2022-500137-89-00 Vasopressin and Steroids in addition to Adrenaline in cardiac arrest -a randomized clinical trial Tiohundra AB

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. In hospital cardiac arrest patients meeting criteria for adrenaline administration according to current ERC guidelines are eligible for the study

Exclusion criteria 1

  1. Patient under 18 years of age, Women considered of childbearing potential (WOCBP) i. e. premenopausal women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Survival at 30 days

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Adrenalin Aguettant 0,1 mg/ml, injektionsvätska, lösning i förfylld spruta

PRD8364439 · Product

Active substance
Epinephrine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
20 mg milligram(s)
Max total dose
20 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
C01CA24 — EPINEPHRINE
Marketing authorisation
52213
MA holder
LABORATOIRE AGUETTANT
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Empressin 40 IE/2 ml koncentrat till infusionsvätska, lösning

PRD7094020 · Product

Active substance
Argipressin
Substance synonyms
ARGININE VASOPRESSIN
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
100 IU international unit(s)
Max total dose
100 IU international unit(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
H01BA01 — VASOPRESSIN
Marketing authorisation
55407
MA holder
ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Solu-Cortef 100 mg pulver och vätska till injektionsvätska, lösning.

PRD566975 · Product

Active substance
Hydrocortisone
Substance synonyms
CORTISOL
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
300 mg milligram(s)
Max total dose
3000 mg milligram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
H02AB09 — HYDROCORTISONE
Marketing authorisation
05561
MA holder
PFIZER AB
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Solu-Medrol 40 mg pulver och vätska till injektionsvätska, lösning

PRD547753 · Product

Active substance
Methylprednisolone
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
09408
MA holder
PFIZER AB
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Tiohundra AB

2 Total trials
Academic / Non-commercial
Sponsor organisation
Tiohundra AB
Address
Roslagsgatan 6
City
Norrtälje
Postcode
761 31
Country
Sweden

Scientific contact point

Organisation
Tiohundra AB
Contact name
Sune Forsberg

Public contact point

Organisation
Tiohundra AB
Contact name
Sune Forsberg

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Temporarily halted 1,400 3
Rest of world — 0 —

Investigational sites

Sweden

3 sites · Temporarily halted
Tiohundra AB
Intensive Care, Malsta, Roslagsgatan 6, Norrtalje
Södersjukhuset Sachsska Barnsjukhuset
Medical Intensive Care, Sjukhusbacken 10, 118 83, Stockholm
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Dept Cardiology, Journalvagen 10, Harlanda, Gothenburg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2025-04-02 2025-04-02 2025-04-02

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Temporary halt TH-78581

Halt date
2025-04-02
Planned restart
2026-02-15
Member states concerned
Sweden
Publication date
2025-04-09
Reason
Sponsor decision
Explanation
We need more sites. We need to simplify the protocol and recruitment strategies.
Follow-up measures
all subject included has been followed up and no further treatment or follow up is planned.
Benefit-risk balance changed
No
Treatment stopped
Yes

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) 4 VAST-A Study_protocol Version_8_20251126_clean_version 8
Protocol (for publication) VAST-A Study_protocolVersion_8_20251126_traced_changes 8
Recruitment arrangements (for publication) Rekryteringsforfarandet 1
Subject information and informed consent form (for publication) VAST-AAllman20220730 1
Subject information and informed consent form (for publication) VAST-AConsentAllman20220107 1
Subject information and informed consent form (for publication) VASTA IC Andringsansokan 20220730 1
Summary of Product Characteristics (SmPC) (for publication) Adrenalin 1
Summary of Product Characteristics (SmPC) (for publication) Adrenalin 1
Summary of Product Characteristics (SmPC) (for publication) Adrenalin 1
Summary of Product Characteristics (SmPC) (for publication) Adrenalin 1
Summary of Product Characteristics (SmPC) (for publication) Empressin 1
Summary of Product Characteristics (SmPC) (for publication) Empressin 1
Summary of Product Characteristics (SmPC) (for publication) Empressin 1
Summary of Product Characteristics (SmPC) (for publication) Empressin 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Cortef 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Cortef 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Cortef 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Cortef 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Medrol 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Medrol 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Medrol 1
Summary of Product Characteristics (SmPC) (for publication) Solu-Medrol 1
Synopsis of the protocol (for publication) Svenskt synopsis nov 2025 1
Synopsis of the protocol (for publication) Synopsis VAST-A 20251209 tracad 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-02-19 Sweden Acceptable
2025-03-31
 2025-04-02
2 SUBSTANTIAL MODIFICATION SM-1 2025-11-27 Sweden Acceptable
2026-02-03
 2026-02-03

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