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Colchicine for ischemia with no obstructive coronary artery disease and microvascular dysfunction
EU CTIS ID: 2023-507981-17-00
What this study is testing
Improved coronary flow and coronary flow reserve in patients with angina symptoms and coronary microvascular disease
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Have CMD, defined as myocardial blodflow reserve (MBFR) < 2.5 or hyperemic myocardial blood flow (hMBF) < 2.3ml/g/min
- • No obstructive CAD as determined by the clinical assessment of [15O]H2O-PET
You likely can't join if
- • Females of childbearing potential. The female patient must either be postmenopausal for at least 1 year or surgically sterile.
- • Patient with a history of an allergic reaction or sensitivity to adenosine or mannitol.
- • Patient with Atrioventricular block grade II or III, or sick sinus syndrome, not protected by a pacemaker.
- • Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment.
- • Patients with severe hypovolemia or hypotension (defined as systolic blood pressure < 90mmHg)
- • Patients with unstable angina pectoris
See the full eligibility criteria
Who can join
- • Have CMD, defined as myocardial blodflow reserve (MBFR) < 2.5 or hyperemic myocardial blood flow (hMBF) < 2.3ml/g/min
- • No obstructive CAD as determined by the clinical assessment of [15O]H2O-PET
What rules you out
- • Females of childbearing potential. The female patient must either be postmenopausal for at least 1 year or surgically sterile.
- • Patient with a history of an allergic reaction or sensitivity to adenosine or mannitol.
- • Patient with Atrioventricular block grade II or III, or sick sinus syndrome, not protected by a pacemaker.
- • Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment.
- • Patients with severe hypovolemia or hypotension (defined as systolic blood pressure < 90mmHg)
- • Patients with unstable angina pectoris
- • Patient with increased intracranial pressure.
- • Patient with a history of an allergic reaction or significant sensitivity to colchicine.
- • Patient in treatment with Potent CYP3A4-/P-gp-inhibitors: o Amiodaron o Amprenavir* o Atazanavir* o Clarithromycin* o Diltiazem o Erythromycin o Telithromycin o Azitromycin o Fluvoxamin o Fosamprenavir* o Indinavir* o Itraconazol* o Ketoconazol* o Lopinavir o Saquinavir o Nelfinavir o Fosamprenavir o Indinavir o Ritonavir* o Verapamil o Voriconazol* o Pyridamole o Roxithromycin o Ciclosporine o Or has a massive Grapefruit consumption
- • Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- • Patient with heart failure, defined as left ventricular ejection fraction of less than 40%[44]
- • Male patients who are planning to impregnate their partner within the individual participation period in the trial and 6 months after last dose.
- • Patient with uncontrolled hypertension (defined as blood pressure above target 140/90 for all) )
- • Patient with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or patient with chronic diarrhea.
- • Patient with any of the following as measured within the past 30 days, and determined to be non-transient through repeat testing: Anemia, thrombocytopenia, leucopenia, liver disease, or kidney disease defined as any of the following measurements within the last 3 months: o hemoglobin < 7mmol/L, o white blood cell count < 3.0 X 109/L, o platelet count <110 X 109/L, o ALT > 3 times the upper limit of normal, o total bilirubin > 2 times upper limit of normal o Serum Creatinine >150mmol/l or eGFR<50mL/min
- • Patients in treatment with anticoagulants. NOACs: Eliquis, Lixiana, Pradaxa, Xarelto, or Warfarin
- patient with severe valve disease
- • Patient with a history of cirrhosis, chronic active hepatitis, or severe hepatic disease.
- • Patient with a history of clinically significant drug or alcohol abuse in the last year.
- • Patient is currently using or plans to begin chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids are allowed).
- • Patient with liver disease
- • Patient with kidney disease or kidney impairment, defined as Serum Creatinine >150mmol/l or eGFR<50mL/min
- • Male patients, having intercourse with fertile women, not willing to use contraception.
- • Patient with lactose intolerance
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.