Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients with Cardiogenic Shock from Acute Myocardial Infarction - NORshock

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

29 Feb 2024 → ongoing

Decision date (initial)

2025-04-17

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-510892-40-00

EudraCT number

2021-005551-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of this study is to test whether a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock is superior to standard care in terms of combined all-cause mortality and renal failure at 30 days.

Secondary objectives 2

1. Does a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock lead to lower all-cause mortality at 30 days?
2. Does a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock lead to an increase of days alive and out of hospital at 30 days?

Conditions and MedDRA coding

Acute myocardial infarction complicated by cardiogenic shock

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Acute myocardial infarction, STEMI or NSTEMI
2. Early revascularization by PCI
3. Cardiogenic shock, characterized by: I. a. Systolic blood pressure (SBP) < 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at presentation before randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria: a. Altered mental status b. Cold, clammy skin and extremities c. Oliguria with urine output < 30ml/hour d. Serum lactate > 2.0 mmol/L III. Clinical signs of pulmonary congestion

Exclusion criteria 5

1. Resuscitation > 30 minutes
2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
3. Onset of shock > 12 hours
4. Imminent need for mechanical circulatory support (i.e. ECPR patients)
5. Women < 45 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is the composite of all-cause mortality and severe renal failure requiring renal replacement therapy within 30 days after randomization.

Secondary endpoints 2

1. All-cause mortality at 30 days
2. Days alive and out of hospital (30 days)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Amsterdam UMC

Public contact point

Organisation

Amsterdam UMC

Contact name

Amsterdam UMC

Locations

9 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 62 files

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

Application history

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