Renin Angiotensin SystemSTOPORNOTNCT03374449
Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery
A study testing continuation of the RAS-inhibitors and discontinuation of the RAS-inhibitors in people with Renin Angiotensin System and Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renin Angiotensin System, Surgery
- What is being tested?
- continuation of the RAS-inhibitors and discontinuation of the RAS-inhibitors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,222 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2018to 24 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring major non-cardiac surgery (surgery with an expected duration of more than 2 hours from the surgical incision and a post-operative hospital stay of least 3 days) (according to the study RELIEF, DOI : 10.1056/NEJMoa1801601))
- Age≥18 years
- Patients chronically treated (>3 months before surgery) with RAS inhibitors
- Pregnancy test at inclusion visit for women of childbearing potential Women of childbearing potential must agree to use adequate contraception according to Recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG)
- Signed informed consent
Who cannot join
- Emergency surgery (surgical treatment needed within 24 hours)
- Hyperkalemia (> 5.5mmol/L) known at the time of the anesthetic consultation
- Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 1 month
- Patient with severe renal insufficiency, known at the time of the anesthestic consultation (as defined by estimated glomerular filtration rate (creatinine clearance <15 ml/min/1.73m2 or requiring renal replacement therapy)
- Patient with preoperative shock (defined by the need for vasoactive drugs before surgery)
- Inability to obtain informed consent either from the patient.
- Lack of Social Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery : a Multicenter, Prospective, Randomized and Controlled Trial
More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor Blockers (ARBs). To stop or not to stop these medications before major surgery remain unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain lacking and matter of debate. It is much likely that the strategy regarding management of RAS inhibitors in the peri-operative setting have important impact on peri-operative complications.
The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors management before major surgery. While French guidelines are to stop RAS inhibitors patients with hypertension to avoid profound anesthestic-drugs-induced hypotension, international guidelines differ. The American heart association task force states that continuation of RAS inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs before major non cardiac surgery.
Read the detailed description
Multicenter, prospective, randomized, pragmatic, parallel-group clinical trial. The inclusion visit takes place between 4 months and no later than 3 days before the surgery visit.
- The randomization will be performed by the anesthesiologist Control group : RAS-I discontinuation Experimental group: RAS-I continuation
- A prescription for the medication strategy (stopping or pursuing the medication) will be handed to the patient during the anesthesiology consultation.
Five follow-up visits are planned
- Immediately, one hour after the surgery (Day 0)
- Then four follow-up visits are planned on day 1, 2, 7 (or hospital discharge) and 28 days+15 days (43 days maximum) after surgery will be collected data and parameters for study endpoints.
End of research visit is the 28 days+15 days (43 days maximum) follow-up visit.
- Conditions
- Renin Angiotensin System, Surgery
- Being tested
- continuation of the RAS-inhibitors, discontinuation of the RAS-inhibitors
- Keywords
- Major surgery, Postoperative morbidity and mortality, Renin angiotensin system inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuation of the RAS-inhibitorsProcedure or surgery
drug intake
discontinuation of the RAS-inhibitorsProcedure or surgery
no drug intake
| Study group | Role | What they receive |
|---|---|---|
| continuation of the RAS-inhibitors | Experimental | in the continuation of the RAS-inhibitors arm the treatment will be continued until the morning the day of surgery. Receives: Procedure: continuation of the RAS-inhibitors |
| discontinuation of the RAS-inhibitors | Active comparator | In this arm : discontinuation of the RAS-inhibitors 48 hours before surgery Patients won't receive the drug on the morning of the day of the surgery. Receives: Procedure: discontinuation of the RAS-inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome composed of all-cause mortality and major postoperative complications within 28 days after surgery.
Complications will be validated by an adjudication committee, blinded to the treatment arm.
Death; Acute Myocardial infarction; Arterial or venous thrombosis; Stroke; Acute pulmonary oedema; Post-operative cardiogenic shock; Acute severe hypertension crisis; Cardiac arrhythmia requiring therapeutic intervention; Postoperative episodes of sepsis; Postoperative respiratory complication; Need for unplanned intensive care unit admission or readmission; Acute kidney injury: KDIGO criteria Baseline serum creatinine is obtained from the pre-operative blood sample; Surgical complications: need for reoperation for any reason and radiologic interventions for abscess drainage; Severe Hyperkalemia: serum potassium level >5.5 mmol/L and requiring therapeutic intervention (insulin/glucose infusion and/or sodium bicarbonate infusion and/or intravenous B2 agonists and/or intravenous calcium gluconate and/or renal replacement therapy and/or ventricular tachycardia or ventricular fibrillation).
Measured: after surgery until day 28
Secondary outcomes (5)
Episodes of hypotension
Episodes requiring vasopressors administration
Measured: during anesthesia and surgery
Acute kidney injury
according to the KDIGO criteria
Measured: after surgery until day 28
Maximum SOFA score
patients admitted to ICU
Measured: from postoperative day 1 to day 7
Duration of hospital stay
Patients who will be outside the hospital but in other types of health care facilities at day 28 will be considered to have been discharged home
Measured: after surgery until day 28
Hospital free-days
Duration after hospital discharge
Measured: censored at 28 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start6 Feb 2018
- Primary completion24 Dec 2023
- Study completion24 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Renin Angiotensin SystemStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study is to evaluate the impact of Renin-Angiotensin System inhibitors management (Continuation or discontinuation 48 hours before surgery) on outcome in patients undergoing scheduled major non-cardiac surgery (surgery with an expected duration of more than 2 hours from the surgical incision and a post-operative hospital stay of least 3 days)
- Masking
- None (open label)
- Enrolment
- 2,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eienne Gayat, MD, PhD, Principal investigator, Hospital Laribioisière, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374449
- Sponsor's protocol ID
- P160933J
- Acronym
- STOPORNOT
- Status last verified
- May 2024
- First submitted
- 11 Dec 2017
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legrand M, Payen D. Case scenario: Hemodynamic management of postoperative acute kidney injury. Anesthesiology. 2013 Jun;118(6):1446-54. doi: 10.1097/ALN.0b013e3182923e8a. No abstract available.
PubMed 23558177Augoustides JG. Angiotensin blockade and general anesthesia: so little known, so far to go. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):177-9. doi: 10.1053/j.jvca.2008.01.002. No abstract available.
PubMed 18375316Mets B. To stop or not? Anesth Analg. 2015 Jun;120(6):1413-9. doi: 10.1213/ANE.0000000000000758. No abstract available.
PubMed 25988640Mets B, Hennrikus E. Perioperative angiotensin axis blockade, to continue or discontinue, that is the question? Anesth Analg. 2014 Nov;119(5):1223-4. doi: 10.1213/ANE.0000000000000430. No abstract available.
PubMed 25329033Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available.
PubMed 25091544Pirracchio R, Cholley B, Falcone J, Charbonneau H, Delaporte A, Lemoine A, Joosten A, Gayat E, Legrand M; STOP-or-NOT trial group. Impact of continuing renin-angiotensin-aldosterone system inhibitors before surgery on intraoperative hypotensive events: a secondary analysis of the STOP-or-NOT Trial. Br J Anaesth. 2026 Mar;136(3):897-905. doi: 10.1016/j.bja.2025.11.049. Epub 2026 Jan 9.
PubMed 41513520Tang J, Pirracchio R, Cholley B, Joosten A, Birckener J, Falcone J, Charbonneau H, Delaporte A, Chen D, Gayat E, Legrand M. Preoperative Cardiovascular Risk and Postoperative Outcomes by Renin-Angiotensin System Inhibitor Use: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2025 Sep 1;10(9):942-948. doi: 10.1001/jamacardio.2025.1920.
PubMed 40560582Legrand M, Falcone J, Cholley B, Charbonneau H, Delaporte A, Lemoine A, Garot M, Joosten A, Meistelman C, Cheron-Leroy D, Rives JP, Pastene B, Dewitte A, Sigaut S, Danguy des Deserts M, Truc C, Boisson M, Lasocki S, Cuvillon P, Schiff U, Jaber S, Le Guen M, Caillard A, Bar S, Pereira de Souza Neto E, Colas V, Dimache F, Girardot T, Jozefowicz E, Viquesnel S, Berthier F, Vicaut E, Gayat E; Stop-or-Not Trial Group. Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial. JAMA. 2024 Sep 24;332(12):970-978. doi: 10.1001/jama.2024.17123.
PubMed 39212270Legrand M, Futier E, Leone M, Deniau B, Mebazaa A, Plaud B, Coriat P, Rossignol P, Vicaut E, Gayat E; STOP-OR-NOT study investigators. Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial). Trials. 2019 Mar 5;20(1):160. doi: 10.1186/s13063-019-3247-1.
PubMed 30836981
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery : a Multicenter, Prospective, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT03374449
- Acronym / sponsor ID
- STOPORNOT / P160933J
- Conditions
- Renin Angiotensin System, Surgery
- Keywords
- Major surgery, Postoperative morbidity and mortality, Renin angiotensin system inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,222 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor Blockers (ARBs). To stop or not to stop these medications before major surgery remain unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain lacking and matter of debate. It is much likely that the strategy regarding management of RAS inhibitors in the peri-operative setting have important impact on peri-operative complications.
The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors management before major surgery. While French guidelines are to stop RAS inhibitors patients with hypertension to avoid profound anesthestic-drugs-induced hypotension, international guidelines differ. The American heart association task force states that continuation of RAS inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs before major non cardiac surgery.
Detailed description
Multicenter, prospective, randomized, pragmatic, parallel-group clinical trial. The inclusion visit takes place between 4 months and no later than 3 days before the surgery visit.
- The randomization will be performed by the anesthesiologist Control group : RAS-I discontinuation Experimental group: RAS-I continuation
- A prescription for the medication strategy (stopping or pursuing the medication) will be handed to the patient during the anesthesiology consultation.
Five follow-up visits are planned
- Immediately, one hour after the surgery (Day 0)
- Then four follow-up visits are planned on day 1, 2, 7 (or hospital discharge) and 28 days+15 days (43 days maximum) after surgery will be collected data and parameters for study endpoints.
End of research visit is the 28 days+15 days (43 days maximum) follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The aim of this study is to evaluate the impact of Renin-Angiotensin System inhibitors management (Continuation or discontinuation 48 hours before surgery) on outcome in patients undergoing scheduled major non-cardiac surgery (surgery with an expected duration of more than 2 hours from the surgical incision and a post-operative hospital stay of least 3 days)
| Arm | Type | Receives |
|---|---|---|
| continuation of the RAS-inhibitors | Experimental | Procedure: continuation of the RAS-inhibitorsin the continuation of the RAS-inhibitors arm the treatment will be continued until the morning the day of surgery. |
| discontinuation of the RAS-inhibitors | Active comparator | Procedure: discontinuation of the RAS-inhibitorsIn this arm : discontinuation of the RAS-inhibitors 48 hours before surgery Patients won't receive the drug on the morning of the day of the surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring major non-cardiac surgery (surgery with an expected duration of more than 2 hours from the surgical incision and a post-operative hospital stay of least 3 days) (according to the study RELIEF, DOI : 10.1056/NEJMoa1801601))
- Age≥18 years
- Patients chronically treated (>3 months before surgery) with RAS inhibitors
- Pregnancy test at inclusion visit for women of childbearing potential Women of childbearing potential must agree to use adequate contraception according to Recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG)
- Signed informed consent
Key exclusion criteria (7 listed)
- Emergency surgery (surgical treatment needed within 24 hours)
- Hyperkalemia (> 5.5mmol/L) known at the time of the anesthetic consultation
- Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 1 month
- Patient with severe renal insufficiency, known at the time of the anesthestic consultation (as defined by estimated glomerular filtration rate (creatinine clearance <15 ml/min/1.73m2 or requiring renal replacement therapy)
- Patient with preoperative shock (defined by the need for vasoactive drugs before surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuation of the RAS-inhibitorsdrug intake | Procedure or surgery | continuation of the RAS-inhibitors |
| discontinuation of the RAS-inhibitorsno drug intake | Procedure or surgery | discontinuation of the RAS-inhibitors |
Primary outcome
composite outcome composed of all-cause mortality and major postoperative complications within 28 days after surgery.
Time frame: after surgery until day 28
Complications will be validated by an adjudication committee, blinded to the treatment arm. Death; Acute Myocardial infarction; Arterial or venous thrombosis; Stroke; Acute pulmonary oedema; Post-operative cardiogenic shock; Acute severe hypertension crisis; Cardiac arrhythmia requiring therapeutic intervention; Postoperative episodes of sepsis; Postoperative respiratory complication; Need for unplanned intensive care unit admission or readmission; Acute kidney injury: KDIGO criteria Baseline serum creatinine is obtained from the pre-operative blood sample; Surgical complications: need for reoperation for any reason and radiologic interventions for abscess drainage; Severe Hyperkalemia: serum potassium level >5.5 mmol/L and requiring therapeutic intervention (insulin/glucose infusion and/or sodium bicarbonate infusion and/or intravenous B2 agonists and/or intravenous calcium gluconate and/or renal replacement therapy and/or ventricular tachycardia or ventricular fibrillation).
5 secondary outcomes
Episodes of hypotension
Time frame: during anesthesia and surgery
Acute kidney injury
Time frame: after surgery until day 28
Maximum SOFA score
Time frame: from postoperative day 1 to day 7
Duration of hospital stay
Time frame: after surgery until day 28
Hospital free-days
Time frame: censored at 28 days following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 23558177Legrand M, Payen D. Case scenario: Hemodynamic management of postoperative acute kidney injury. Anesthesiology. 2013 Jun;118(6):1446-54. doi: 10.1097/ALN.0b013e3182923e8a. No abstract available.
- Background: PubMed 18375316Augoustides JG. Angiotensin blockade and general anesthesia: so little known, so far to go. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):177-9. doi: 10.1053/j.jvca.2008.01.002. No abstract available.
- Background: PubMed 25988640Mets B. To stop or not? Anesth Analg. 2015 Jun;120(6):1413-9. doi: 10.1213/ANE.0000000000000758. No abstract available.
- Background: PubMed 25329033Mets B, Hennrikus E. Perioperative angiotensin axis blockade, to continue or discontinue, that is the question? Anesth Analg. 2014 Nov;119(5):1223-4. doi: 10.1213/ANE.0000000000000430. No abstract available.
- Background: PubMed 25091544Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available.
- Derived from this study: PubMed 41513520Pirracchio R, Cholley B, Falcone J, Charbonneau H, Delaporte A, Lemoine A, Joosten A, Gayat E, Legrand M; STOP-or-NOT trial group. Impact of continuing renin-angiotensin-aldosterone system inhibitors before surgery on intraoperative hypotensive events: a secondary analysis of the STOP-or-NOT Trial. Br J Anaesth. 2026 Mar;136(3):897-905. doi: 10.1016/j.bja.2025.11.049. Epub 2026 Jan 9.
- Derived from this study: PubMed 40560582Tang J, Pirracchio R, Cholley B, Joosten A, Birckener J, Falcone J, Charbonneau H, Delaporte A, Chen D, Gayat E, Legrand M. Preoperative Cardiovascular Risk and Postoperative Outcomes by Renin-Angiotensin System Inhibitor Use: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2025 Sep 1;10(9):942-948. doi: 10.1001/jamacardio.2025.1920.
- Derived from this study: PubMed 39212270Legrand M, Falcone J, Cholley B, Charbonneau H, Delaporte A, Lemoine A, Garot M, Joosten A, Meistelman C, Cheron-Leroy D, Rives JP, Pastene B, Dewitte A, Sigaut S, Danguy des Deserts M, Truc C, Boisson M, Lasocki S, Cuvillon P, Schiff U, Jaber S, Le Guen M, Caillard A, Bar S, Pereira de Souza Neto E, Colas V, Dimache F, Girardot T, Jozefowicz E, Viquesnel S, Berthier F, Vicaut E, Gayat E; Stop-or-Not Trial Group. Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial. JAMA. 2024 Sep 24;332(12):970-978. doi: 10.1001/jama.2024.17123.
- Derived from this study: PubMed 30836981Legrand M, Futier E, Leone M, Deniau B, Mebazaa A, Plaud B, Coriat P, Rossignol P, Vicaut E, Gayat E; STOP-OR-NOT study investigators. Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial). Trials. 2019 Mar 5;20(1):160. doi: 10.1186/s13063-019-3247-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eienne Gayat, MD, PhD principal investigator
Hospital Laribioisière, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuation of the RAS-inhibitors and discontinuation of the RAS-inhibitors in people with Renin Angiotensin System and Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome composed of all-cause mortality and major postoperative complications within 28 days after surgery. (time frame: after surgery until day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374449, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.