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New treatment option for Cardiovascular Diseases
Official title Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
ClinicalTrials.gov ID: NCT06279000
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cardiovascular diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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)
See the full eligibility criteria
- 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:
- 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
- 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sankt Gallen, Canton of St. Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sankt Gallen, Canton of St. Gallen, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.