2023-507981-17-00招募中2 期
Colchicine for ischemia with no obstructive coronary artery disease and microvascular dysfunction
Region Hovedstaden, Region Hovedstaden1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月19日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in myocardial bloodflow reserve assessed by [15O]H2O-PET-scan from baseline and after 6 months
研究概览
简要总结
Improved coronary flow and coronary flow reserve in patients with angina symptoms and coronary microvascular disease
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Change in myocardial bloodflow reserve assessed by [15O]H2O-PET-scan from baseline and after 6 months
Change in myocardial bloodflow reserve assessed by [15O]H2O-PET-scan from baseline and after 6 months
次要结局
- Change in Symptom burden assessed by Seattle Angina Questionnaire at baseline and 6 months
- Identifying certain protein pathways and functional mechanisms in arteries associated with colchicine treatment.
- Changes in vascular function and protein pathway analyses in subsamples
- Change in MBF assessed by [15O]H2O-PET-scan from baseline and after 6 months
- Change in hMBF assessed by [15O]H2O-PET-scan from baseline and after 6 months
研究者
Information deck
Scientific
Bispebjerg Hospital
研究点 (1)
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