Cardiovascular DiseasesPhase 3COLCATNCT06279000
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
A Phase 3 study testing Colchicine in people with Cardiovascular Diseases and Cardiovascular Complication, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery. However, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury/MACE. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Complication, Perioperative Complication
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 880 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2025to 30 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:
- vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
- intraperitoneal surgery
- intrathoracic surgery
- major orthopaedic surgery (spinal surgery or joint replacement surgery)
- at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
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- preoperative n-terminal pro brain natriuretic peptide (NT-proBNP) ≥ 200 ng/l
- history of coronary artery disease
- history of peripheral vascular disease
- history of stroke
- undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies
- fulfilment of any 3 of the 8 following criteria:
- undergoing major surgery (intrathoracic, intraperitoneal or supra-inguinal vascular surgery)
- any history of congestive heart failure or history of pulmonary oedema
- anamnestic transient ischemic attack (TIA)
- diabetes under treatment with either oral antidiabetic agent or insulin
- age \> 70 years
- history of hypertension
- serum creatinine \> 175 mumol/l or calculated creatinine clearance \< 60 ml/min/1.73m2 (cockcroft gault)
- history of smoking within 2 years of surgery
- planned surgical time ≥ 90 minutes
- planned postoperative hospital stay at least 1 night
Who cannot join
- no written consent
- inclusion in other clinical trial with direct impact on perioperative medication
- previously reported side effects or reported intolerance from colchicine (e.g., allergic reaction or significant sensitivity to colchicine or an auxiliary substance of the IMP)
- pregnancy or planned pregnancy and/or breast feeding
- clinically significant history of drug or alcohol abuse within the last year
- very severe frailty (≥ 8 clinical frailty scale)
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- patient with inflammatory bowel disease (e.g., Morbus Crohn or Colitis ulcerosa)
- patient taking colchicine for other indications (e.g., familial Mediterranean fever, gout)
- severe renal impairment (eGFR \< 30 ml min -1 1.73 m2 -1) or end-stage renal disease with indication for haemodialysis
- history of solid organ or bone marrow transplantation
- systemic immune-suppression (medication (steroids \>30mg cortisol-equivalent per day, tacrolimus etc...) or disease (e.g., myelodysplastic syndrome)
- severe hepatic impairment with history of cirrhosis
- chronic active hepatitis or functional disorders defined as alanine aminotransferase greater than three times the upper limit of normal
- anticipated post-operative administration of CYP3A4 metabolized substances like cyclosporine, ketoconazole, clarithromycin, verapamil, quinidine, diltiazem or ritonavir
- Any other condition that the investigator would consider a risk to the patient if the latter were to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Timur Yurttas, MD, 0041714949158, timur.yurttas@kssg.ch
Timur Yurttas, MD
About this study
Official title: Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study
Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.
However, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.
These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of myocardial injury/MACE.
Read the detailed description
This double-blind, placebo-controlled study is conducted at the Cantonal Hospital St. Gallen and the University Hospital Basel, Switzerland. The investigators intend to expand the participant recruitment to other centers. Inclusion criteria encompass patients' cardiovascular risk profile and vascular, orthopedic, visceral, and thoracic surgical procedures with a high risk as determined by the recognized incidence of troponin dynamics. Patients are informed during preoperative consultation and provide consent prior to randomization to the colchicine or placebo groups. The preoperative assessment includes medical history, medication use and physical capacity. Baseline values and cardiac biomarkers, are determined through routine laboratory tests. Study medication is administered from the evening before surgery until the third postoperative day. Daily high-sensitivity cardiac troponin T (hs-cTnT) testing is performed until the fourth day. Visits monitor primary, secondary, and safety endpoints, with standard treatment for complications. Post-hospitalization, cardiovascular events will be recorded until postoperative day 30 and for one year post-surgery to assess long-term outcomes.
The primary objective is to evaluate the efficacy of perioperative colchicine administration in cardiac-risk patients undergoing major non-cardiac surgery, with the aim of reducing the myocardial injury incidence until postoperative day 4 and mitigate postoperative MACE until postoperative day 30. Secondary objectives include whether perioperative administration of colchicine reduces new-onset atrial fibrillation incidence postoperatively (until discharge) compared to placebo, to quantify the maximum increase in postoperative hs-cTnT concentrations until postoperative day 4 and to assess the impact of perioperative colchicine administration on long-term survival and morbidity (composite of MACE) after one year. The safety objectives are the incidence of gastrointestinal adverse events and clinically adverse events attributable to the administration of colchicine.
- Conditions
- Cardiovascular Diseases, Cardiovascular Complication, Perioperative Complication, Myocardial Injury, Myocardial Injury After Noncardiac Surgery (MINS)
- Being tested
- Colchicine, Placebo
- Keywords
- Perioperative Cardiovascular Risk, myocardial injury, major adverse cardiac events, colchicine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine Group:
IMP = Colchicine (0.5 mg, enteral) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Colchicine tablets are provided as 1 mg tablets with a score, which must be divided before ingestion.
PlaceboDrug
Also called Control
Placebo Group:
Placebo (identical to IMP in appearance and application) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Placebo tablets are provided as tablets with a score, which must be divided before ingestion.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | The first dose of the IMP is administered in the evening prior to the surgical procedure. Administrations of the study drug follow a 1-0-1 schedule (colchicine 0.5 mg per intake). The last study drug is administered in the evening of the third postoperative day. Receives: Drug: Colchicine |
| Control (Placebo) | Placebo comparator | Patients in the control group will receive the same perioperative anaesthetic, surgical and medical treatment as patients in the experimental group, the sole difference being that patients will be given a placebo instead of the IMP colchicine.
The first dose of the placebo is administered in the evening prior to the surgical procedure. Administrations of the placebo follow a 1-0-1 schedule. The last placebo is administered in the evening of the third postoperative day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Proportion of patients developing MACE in the peri- postoperative course. MACE is defined as a composite of any of the following within 30 days following surgery:
- Acute coronary syndrome
- New/worsening congestive heart failure
- Coronary revascularization
- Stroke
- All-cause mortality
- Cardiovascular death
Measured: until postoperative day 30
Myocardial Injury
Proportion of patients developing myocardial injury in the peri- postoperative course. The primary outcome is a composite of myocardial injury and 30-day MACE. Myocardial injury is defined as an absolute perioperative rise in hs-cTnT of ≥ 14 ng/l above preoperative values (or between two postoperative measurements, if preoperative hs-cTnT is missing).
Measured: until postoperative day 4
Secondary outcomes (3)
New onset Atrial fibrillation
Proportion of patients developing new-onset atrial fibrillation in the peri- postoperative course. The time frame includes the time from beginning of surgery (ECG monitoring in the peri- and early postoperative course on postoperative care unit/intensive care unit) until the date of first documented occurrence of atrial fibrillation (perioperative monitoring by daily nurse-controlled pulse examination, verified by an ECG in case of suspected arrhythmia/atrial fibrillation). These monitoring procedures take place until the discharge from the hospital.
Measured: From beginning of surgery/surgical procedures until the date of first documented occurrence or until postoperative day 30/discharge from hospital, whatever comes first
postoperative high sensitive cardiac Troponin T concentrations
Comparison of postoperative hs-cTnT concentrations (maximal increase from individual baseline \& the area under the curve) until postoperative day 4 between the study groups
Measured: until postoperative day 4
long term cardiovascular outcome
Proportion of patients developing MACE in regard of long term cardiovascular outcome after surgery.1-year composite endpoint of MACE (composite of acute coronary syndrome, new or worsening congestive heart failure, coronary revascularization, stroke, all-cause mortality and cardiovascular mortality) as a marker of long-term postoperative outcome.
Measured: until 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start20 Apr 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blinded, placebo-controlled, multicenter
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Timur Yurttas, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279000
- Sponsor's protocol ID
- CTU 22/025
- Acronym
- COLCAT
- Status last verified
- Sep 2024
- First submitted
- 12 Feb 2024
- Last updated
- 24 Apr 2025
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study
- ClinicalTrials.gov ID
- NCT06279000
- Acronym / sponsor ID
- COLCAT / CTU 22/025
- Conditions
- Cardiovascular Diseases, Cardiovascular Complication, Perioperative Complication, Myocardial Injury, Myocardial Injury After Noncardiac Surgery (MINS)
- Keywords
- Perioperative Cardiovascular Risk, myocardial injury, major adverse cardiac events, colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 26 Feb 2024 (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.
Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.
However, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.
These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of myocardial injury/MACE.
Detailed description
This double-blind, placebo-controlled study is conducted at the Cantonal Hospital St. Gallen and the University Hospital Basel, Switzerland. The investigators intend to expand the participant recruitment to other centers. Inclusion criteria encompass patients' cardiovascular risk profile and vascular, orthopedic, visceral, and thoracic surgical procedures with a high risk as determined by the recognized incidence of troponin dynamics. Patients are informed during preoperative consultation and provide consent prior to randomization to the colchicine or placebo groups. The preoperative assessment includes medical history, medication use and physical capacity. Baseline values and cardiac biomarkers, are determined through routine laboratory tests. Study medication is administered from the evening before surgery until the third postoperative day. Daily high-sensitivity cardiac troponin T (hs-cTnT) testing is performed until the fourth day. Visits monitor primary, secondary, and safety endpoints, with standard treatment for complications. Post-hospitalization, cardiovascular events will be recorded until postoperative day 30 and for one year post-surgery to assess long-term outcomes.
The primary objective is to evaluate the efficacy of perioperative colchicine administration in cardiac-risk patients undergoing major non-cardiac surgery, with the aim of reducing the myocardial injury incidence until postoperative day 4 and mitigate postoperative MACE until postoperative day 30. Secondary objectives include whether perioperative administration of colchicine reduces new-onset atrial fibrillation incidence postoperatively (until discharge) compared to placebo, to quantify the maximum increase in postoperative hs-cTnT concentrations until postoperative day 4 and to assess the impact of perioperative colchicine administration on long-term survival and morbidity (composite of MACE) after one year. The safety objectives are the incidence of gastrointestinal adverse events and clinically adverse events attributable to the administration of colchicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blinded, placebo-controlled, multicenter
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineThe first dose of the IMP is administered in the evening prior to the surgical procedure. Administrations of the study drug follow a 1-0-1 schedule (colchicine 0.5 mg per intake). The last study drug is administered in the evening of the third postoperative day. |
| Control (Placebo) | Placebo comparator | Drug: PlaceboPatients in the control group will receive the same perioperative anaesthetic, surgical and medical treatment as patients in the experimental group, the sole difference being that patients will be given a placebo instead of the IMP colchicine. The first dose of the placebo is administered in the evening prior to the surgical procedure. Administrations of the placebo follow a 1-0-1 schedule. The last placebo is administered in the evening of the third postoperative day. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- undergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:
- vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
- intraperitoneal surgery
- intrathoracic surgery
- major orthopaedic surgery (spinal surgery or joint replacement surgery)
Key exclusion criteria (15 listed)
- no written consent
- inclusion in other clinical trial with direct impact on perioperative medication
- previously reported side effects or reported intolerance from colchicine (e.g., allergic reaction or significant sensitivity to colchicine or an auxiliary substance of the IMP)
- pregnancy or planned pregnancy and/or breast feeding
- clinically significant history of drug or alcohol abuse within the last year
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 |
|---|---|---|
| ColchicineColchicine Group: IMP = Colchicine (0.5 mg, enteral) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Colchicine tablets are provided as 1 mg tablets with a score, which must be divided before ingestion. | Drug | Colchicine |
| PlaceboAlso: ControlPlacebo Group: Placebo (identical to IMP in appearance and application) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Placebo tablets are provided as tablets with a score, which must be divided before ingestion. | Drug | Control (Placebo) |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: until postoperative day 30
Proportion of patients developing MACE in the peri- postoperative course. MACE is defined as a composite of any of the following within 30 days following surgery: * Acute coronary syndrome * New/worsening congestive heart failure * Coronary revascularization * Stroke * All-cause mortality * Cardiovascular death
Myocardial Injury
Time frame: until postoperative day 4
Proportion of patients developing myocardial injury in the peri- postoperative course. The primary outcome is a composite of myocardial injury and 30-day MACE. Myocardial injury is defined as an absolute perioperative rise in hs-cTnT of ≥ 14 ng/l above preoperative values (or between two postoperative measurements, if preoperative hs-cTnT is missing).
3 secondary outcomes
New onset Atrial fibrillation
Time frame: From beginning of surgery/surgical procedures until the date of first documented occurrence or until postoperative day 30/discharge from hospital, whatever comes first
postoperative high sensitive cardiac Troponin T concentrations
Time frame: until postoperative day 4
long term cardiovascular outcome
Time frame: until 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- 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.
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 Colchicine in people with Cardiovascular Diseases and Cardiovascular Complication, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 22 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timur Yurttas, MD (0041 714949158, timur.yurttas@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: until postoperative day 30). The study lists 2 primary outcomes in all. 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 24 Apr 2025.