Myocardium; InjuryPhase 3NCT06862115
The Effect of Discontinuation of Renin Angiotensin System Inhibitors on the Perioperative Myocardial Injury in Adult Patients Undergoing Colorectal Cancer Surgery
A Phase 3 study testing ACE-I and/or ARB antihypertensive treatment in people with Myocardium; Injury and Perioperative/Postoperative Complications, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to estimate the effect of discontinuation of RAS inhibitors on myocardial injury in cancer patients undergoing major abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myocardium; Injury, Perioperative/Postoperative Complications, Angiotensin-Converting-Enzyme Inhibitor
- What is being tested?
- ACE-I and/or ARB antihypertensive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 10 Aug 2026
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Both sexes
- ASA 2-3
- Chronic hypertensive patients (> 3 months before surgery) controlled on ACEIs or ARBs or combination therapy containing one of the RAS inhibitors.
- Scheduled for major abdominal cancer surgery (surgery with an expected duration of > 2 h from the surgical incision and a postoperative hospital stay of least three days).
Who cannot join
- Patient refusal.
- Recent myocardial infarction (within 3 months).
- Any condition, which in the opinion of the treating clinician, would result in the patient being harmed by the cessation of the ACE-I and/or ARB therapy.
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Discontinuation of Renin Angiotensin System Inhibitors on the Perioperative Myocardial Injury in Adult Patients Undergoing Colorectal Cancer Surgery: a Randomized Controlled Non Inferiority Study.
The aim of this study is to estimate the effect of discontinuation of RAS inhibitors on myocardial injury in cancer patients undergoing major abdominal surgeries.
Read the detailed description
This is a prospective, open-label, randomized controlled non inferiority trial. Participants will be assigned randomly in a 1:1 manner whether to stop or continue RAS inhibitors. Randomization will be performed using an online program (www.randomizer.com).
Trial participants and staff will not be blinded to treatment group allocation however, all investigators will be blinded to the primary outcome measure (myocardial injury).
After randomization during the preoperative visit, participants will be instructed to stop or continue their ACE-I and/or ARB according to their allocated group. ACE-I and/or ARB will be continued or discontinued as per treatment group allocation and this will continue until 24 hours after the end of surgery. Since ACE-I and ARB have different durations of action, participants will receive drug-specific instructions as to when to stop. When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery. Renin-angiotensin system inhibitors will be restarted after surgery on the morning of post-operative day one if systolic blood pressure was >120 mmHg in the previous 12 hours.
The anesthetic induction, intraoperative and postoperative management will be managed according to the local policy of the NCI by expert anesthesiologists who will be blinded to the patients' groups.
Troponin-I will be measured at 9 a.m. on the day before surgery and at 9 a.m. on postoperative day one and day two. Myocardial injury will be defined as: (Troponin-I an increase by 0.015 is considered positive, if the baseline is <0.05 A. If the baseline is higher than 0.05, an increase by 0.005 is considered positive).
- Conditions
- Myocardium; Injury, Perioperative/Postoperative Complications, Angiotensin-Converting-Enzyme Inhibitor
- Being tested
- ACE-I and/or ARB antihypertensive treatment
- Medical subject headings
- Wounds and Injuries, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE-I and/or ARB antihypertensive treatmentDrug
When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| stop RAS | Experimental | When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery. Receives: Drug: ACE-I and/or ARB antihypertensive treatment |
| continue RAS | Active comparator | ACE-I and ARBs will be continued till morning of surgery Receives: Drug: ACE-I and/or ARB antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the incidence of myocardial injury 48 hours after surgery
defined as: (Troponin-I If the baseline is <0.05 And increase by 0.015 is considered positive
If the baseline is higher than 0.05, an increase by 0.005 is considered positive
Measured: 48 hours
Secondary outcomes (4)
Highest level of Troponin-I measured within 48 hours of surgery.
Highest level of Troponin-T measured within 48 hours of surgery.
Measured: 48 hours
Incidence of perioperative hypotension
Incidence of perioperative hypotension (MAP<20% of baseline measure recorded night before surgery) until 48 hours after surgery.
Measured: 48 hours
Incidence of severe hypotension
Incidence of severe hypotension (MAP < 60 mmHg requiring any vasopressor) until 48 hours after surgery.
Measured: 48 hours
Incidence of perioperative severe hypertension
Incidence of perioperative severe hypertension (BP>180/100mmHg) until 48 hours after surgery.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Mar 2025
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardium; InjuryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862115
- Sponsor's protocol ID
- MS-525-2024
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discontinuation of Renin Angiotensin System Inhibitors on the Perioperative Myocardial Injury in Adult Patients Undergoing Colorectal Cancer Surgery: a Randomized Controlled Non Inferiority Study.
- ClinicalTrials.gov ID
- NCT06862115
- Acronym / sponsor ID
- MS-525-2024
- Conditions
- Myocardium; Injury, Perioperative/Postoperative Complications, Angiotensin-Converting-Enzyme Inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 6 Mar 2025 (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.
The aim of this study is to estimate the effect of discontinuation of RAS inhibitors on myocardial injury in cancer patients undergoing major abdominal surgeries.
Detailed description
This is a prospective, open-label, randomized controlled non inferiority trial. Participants will be assigned randomly in a 1:1 manner whether to stop or continue RAS inhibitors. Randomization will be performed using an online program (www.randomizer.com).
Trial participants and staff will not be blinded to treatment group allocation however, all investigators will be blinded to the primary outcome measure (myocardial injury).
After randomization during the preoperative visit, participants will be instructed to stop or continue their ACE-I and/or ARB according to their allocated group. ACE-I and/or ARB will be continued or discontinued as per treatment group allocation and this will continue until 24 hours after the end of surgery. Since ACE-I and ARB have different durations of action, participants will receive drug-specific instructions as to when to stop. When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery. Renin-angiotensin system inhibitors will be restarted after surgery on the morning of post-operative day one if systolic blood pressure was >120 mmHg in the previous 12 hours.
The anesthetic induction, intraoperative and postoperative management will be managed according to the local policy of the NCI by expert anesthesiologists who will be blinded to the patients' groups.
Troponin-I will be measured at 9 a.m. on the day before surgery and at 9 a.m. on postoperative day one and day two. Myocardial injury will be defined as: (Troponin-I an increase by 0.015 is considered positive, if the baseline is <0.05 A. If the baseline is higher than 0.05, an increase by 0.005 is considered positive).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stop RAS | Experimental | Drug: ACE-I and/or ARB antihypertensive treatmentWhen the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery. |
| continue RAS | Active comparator | Drug: ACE-I and/or ARB antihypertensive treatmentACE-I and ARBs will be continued till morning of surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Both sexes
- ASA 2-3
- Chronic hypertensive patients (> 3 months before surgery) controlled on ACEIs or ARBs or combination therapy containing one of the RAS inhibitors.
- Scheduled for major abdominal cancer surgery (surgery with an expected duration of > 2 h from the surgical incision and a postoperative hospital stay of least three days).
Key exclusion criteria (4 listed)
- Patient refusal.
- Recent myocardial infarction (within 3 months).
- Any condition, which in the opinion of the treating clinician, would result in the patient being harmed by the cessation of the ACE-I and/or ARB therapy.
- Emergency 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 |
|---|---|---|
| ACE-I and/or ARB antihypertensive treatmentWhen the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery. | Drug | continue RAS, stop RAS |
Primary outcome
The primary outcome is the incidence of myocardial injury 48 hours after surgery
Time frame: 48 hours
defined as: (Troponin-I If the baseline is <0.05 And increase by 0.015 is considered positive If the baseline is higher than 0.05, an increase by 0.005 is considered positive
4 secondary outcomes
Highest level of Troponin-I measured within 48 hours of surgery.
Time frame: 48 hours
Incidence of perioperative hypotension
Time frame: 48 hours
Incidence of severe hypotension
Time frame: 48 hours
Incidence of perioperative severe hypertension
Time frame: 48 hours
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACE-I and/or ARB antihypertensive treatment in people with Myocardium; Injury and Perioperative/Postoperative Complications, run by Kasr El Aini Hospital at 1 site in Egypt.
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 4 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 19 Aug 2026. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome is the incidence of myocardial injury 48 hours after surgery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.