ACTRN12616000400460招募中3 期
The COLCARDIO-ACS Study - Colchicine Cardiovascular Outcomes in Acute Coronary Syndrome Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients aged equal or greater than 18 years
- •2. Presentation with an Acute Coronary Syndrome (defined as acute myocardial infarction, with or without electrocardiographic evidence of ST-segment elevation, or high-risk unstable angina) and commenced on optimal medical therapy
- •3. hs-CRP equal or greater than 2mg/L (at time of registration 4 - 52 weeks after discharge for an Acute Coronary Syndrome event)
- •4. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •5. Signed written informed consent
- •COLCHICINE-COG
- •1. Be enrolled in COLCARDIO-ACS;
- •2. Be aged 40 - 65 years (at the time of enrolment);
- •3. Be willing and able to comply with sub-study visit schedule and nature of required
- •assessments; and
- •4. Provide signed written informed consent
排除标准
- •1. Any known intolerance to Colchicine
- •2. Pre-existing Colchicine treatment within the last 3 months
- •3. Any known myopathy (any grade or myopathy in present or prior history within the last 3 months or CK >3 x upper limit of normal)
- •4. Severe liver disease or aminotransferase level > 3x upper limit of normal, within the last 3 months
- •5. Blood dyscrasia (white cell count or platelet count < lower limit of normal), within the last 3 months
- •6. Estimated glomerular filtration rate (eGFR) <45 mL/min per 1.73m2 at time of registration
- •7. Prior or current therapy with a strong CYP3A4 inhibitor or inducer or calcineurin inhibitor
- •8. Active autoimmune disease or chronic inflammatory bowel disease (defined as any disease requiring long-term or frequent immunosuppression)
- •9. Haematological malignancy which remains uncured or antineoplastic therapy within the last 3 months
- •10. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •11. Any known comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the investigational product(s) or may compromise assessment of key outcomes.
- •12. Life expectancy of less than 3 years
- •13. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- •14. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
- •COLCHICINE-COG
- •1. Suspected or established dementia diagnosis (MMSE <23);
- •2. Intellectual or developmental disability;
- •3. History of head injury with loss of consciousness >30 minutes;
- •4. History of major neurological illness (e.g. stroke, epilepsy);
- •5. History of psychiatric illness (other than affective disorder e.g. schizophrenia, bipolar
- •6. History of electroconvulsive therapy or deep brain stimulation;
- •7. Current/past alcohol or substance dependence (other than nicotine);
- •8. Any known medical condition which may affect cognition (e.g. cancer, chronic fatigue
- •syndrome); and/or
- •9. Contraindications to magnetic resonance imaging scanning (e.g. aneurysm clip,
- •pacemaker, etc.).
研究者
相似试验
进行中（未招募）
1 期
Colchicine Cardiovascular Outcomes Trialpatients with atherosclerotic coronary artery disease (CAD)EUCTR2014-005172-28-PTMontreal Heart Institute4,500
进行中（未招募）
1 期
Colchicine Cardiovascular Outcomes Trialpatients with atherosclerotic coronary artery disease (CAD)EUCTR2014-005172-28-ESMontreal Heart Institute4,500
进行中（未招募）
1 期
Colchicine Cardiovascular Outcomes Trialpatients with atherosclerotic coronary artery disease (CAD)EUCTR2014-005172-28-FRMontreal Heart Institute4,500
进行中（未招募）
1 期
COLCOT Studypatients with atherosclerotic coronary artery disease (CAD)MedDRA version: 20.0Level: HLGTClassification code 10011082Term: Coronary artery disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: HLTClassification code 10011085Term: Ischaemic coronary artery disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10028595Term: Myocardial infarctSystem Organ Class: 10007541 - Cardiac disordersEUCTR2014-005172-28-ITMONTREAL HEART INSTITUTE4,500
招募中
1 期
COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary InterventioCoronary artery diseaseMedDRA version: 20.0Level: PTClassification code: 10011078Term: Coronary artery disease Class: 100000004849CTIS2023-505028-74-00niversitair Ziekenhuis Gent2,770