Colchicine for ischemia with no obstructive coronary artery disease and microvascular dysfunctio

Phase 1

Active, not recruiting

• Conditions: CMD; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-507981-17-00
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-03
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•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

Exclusion Criteria

•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: oAmiodaron oAmprenavir* oAtazanavir* oClarithromycin* oDiltiazem oErythromycin oTelithromycin oAzitromycin oFluvoxamin oFosamprenavir* oIndinavir* oItraconazol* oKetoconazol* oLopinavir oSaquinavir oNelfinavir oFosamprenavir oIndinavir oRitonavir* oVerapamil oVoriconazol* oPyridamole oRoxithromycin oCiclosporine oOr 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: ohemoglobin < 7mmol/L, owhite blood cell count < 3.0 X 109/L, oplatelet count <110 X 109/L, oALT > 3 times the upper limit of normal, ototal bilirubin > 2 times upper limit of normal oSerum 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified