CTRI/2025/11/098037尚未招募不适用
Efficaacy assessment of low dose colchicine for secondary risk reduction in patients with stable coronary artery disease - A Randomized Controlled Trial
Dr Akshaya Kamalashree1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年12月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
研究概览
简要总结
Consent will be obtained from eligible participants of the study basing on the above mentionedinclusion and exclusion criteria. Demographic information, lifestyle data, and medical history datawill be collected from all participants.. Each participant will be asked to visit the hospital for review after 30 days and after 90 days of starting the drug. Adverse effects in the study population noted.Any primary end point such as cardiovascular death , spontaneous myocardial infarction , ischemic stroke, or ischemia-driven coronary revascularization will be documented during study period .hsCRP will be tested at 3 months if no MACE occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •angiographically proven coronary disease 2) clinically stable greater than 6 months Post CAD diagnosis on regular secondary CAD prevention medications 3) hsCRP greater than 2 mg/L 4) considered compliant with therapy and follow-up at 1 & 3 months 5) willing to provide consent to participate in the study.
排除标准
- •1 ) Renal failure eGFR less than 50 ml per min per 1.73 m2 2 ) Liver failure 3 ) active infection 4 ) Blood dyscrasias 5 ) Auto immune disorders 6 ) on Glucocorticoid therapy 7 ) on Colchicine for gout 8 ) Heart failure LVEF lesser than 40 percent 9 ) Pregnant or breast feeding 10) on strong CYP3A4 ; p- glycoprotein inhibitors – Azole antifungals , clarithromycin , Lopinavir.
研究者
Dr Akshaya Kamalashree
SRM Medical College Hospital and Research Centre
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60
尚未招募
不适用
A clinical study to assess the safety and effectiveness of Moisturizing Lip Balm in Participants having cracked lips.CTRI/2026/03/105458Relaner Ventures Pvt. Ltd.30
招募中
不适用
Clinical trial to evaluate the efficacy and safety of PTFE-coated biliary stentsResectable or borderline resectable pancreatic cancer requiring biliary drainagejRCT106225009840
已完成
2/3 期
To Clinically assess the effect of Babula Phala in Asthikshya (Osteoporosis)CTRI/2024/09/073536Government Ayurved Hospital Vadodara30
尚未招募
2 期
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic CancerNCT07301229Shanghai Henlius Biotech100