Stopping perioperative angiotensin II converting enzyme inhibitors and/or angiotensin receptor blockers in major noncardiac surgery

Stopping Perioperative Angiotensin II Converting Enzyme inhibitors and/or angiotensin receptor blockers in major non-cardiac surgery (SPACE): A phase III, mechanistic, randomised controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17251494

Enrollment

260

Registered

2017-05-29

Start date

2017-06-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing major surgery requiring general anaesthesia Surgery Patients undergoing major surgery requiring general anaesthesia

Interventions

Following provision of informed consent, participants will be randomly allocated to one of two groups (1:1) using a computer generated dynamic procedure (minimisation) with a random component. Minimis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent (no incapacitated or vulnerable adult or minors will be included) 2. Currently taking angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers therapy 3. Age 60 years and over 4. Patients undergoing major surgery (major joint replacement/ vascular/ gastrointestinal) requiring general anesthesia that is expected to take longer than 120 minutes 5. American Society of Anesthesiologists grade 3 or above

Exclusion criteria

Exclusion criteria: 1. Current participation in any other trials 2. Recent myocardial infarction (within 3 months) 3. Any condition, which in the opinion of the treating clinician would result in the patient being harmed by the cessation of the angiotensin II converting enzyme inhibitors and/or angiotensin receptor blockers therapy

Design outcomes

Primary

Measure	Time frame
Troponin-T levels will be measured in blood samples collected immediately before the induction of anaesthesia, and then at 24 and 48 hours after surgery.	—

Secondary

Measure	Time frame
1. Highest level of Troponin-T is assessed on plasma high sensitivity Troponin-T, measured within 48 hours of surgery (continuous variable) 2. Infection of Clavien-Dindo grade II or greater, assessed using a patient medical note review and telephone interview, within 30 days from randomisation 3. Myocardial infarction assessed by patient medical note review and telephone interview, within 30 days from randomisation 4. Acute heart failure assessed using a patient medical note review and telephone interview within 30 days from randomisation 5. Stroke within 30 days from randomisation assessed using a patient medical note review and telephone interview Process measures: 1. Duration of hospital stay (number of days from randomisation until hospital discharge) assessed by a review of the patient's medical records 2. Number of critical care free days, assessed by a review of the patient's medical records, up to 30 days from randomisation A critical care free day is defined as a day in which the patient is alive and is not in a level 2 or level 3 critical care bed.	—

Measure

Time frame

1. Highest level of Troponin-T is assessed on plasma high sensitivity Troponin-T, measured within 48 hours of surgery (continuous variable) 2. Infection of Clavien-Dindo grade II or greater, assessed using a patient medical note review and telephone interview, within 30 days from randomisation 3. Myocardial infarction assessed by patient medical note review and telephone interview, within 30 days from randomisation 4. Acute heart failure assessed using a patient medical note review and telephone interview within 30 days from randomisation 5. Stroke within 30 days from randomisation assessed using a patient medical note review and telephone interview Process measures: 1. Duration of hospital stay (number of days from randomisation until hospital discharge) assessed by a review of the patient's medical records 2. Number of critical care free days*, assessed by a review of the patient's medical records, up to 30 days from randomisation *A critical care free day is defined as a day in which the patient is alive and is not in a level 2 or level 3 critical care bed.

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Countries

England, United Kingdom

Contacts

Public ContactPriyanthi Dias

admin@spacetrial.org+44 20 3594 0352

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026