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Study on the Role of Anti-Inflammatory Therapy in reducing the risk of further cardiac events in patients with Stable Heart Disease

Efficaacy assessment of low dose colchicine for secondary risk reduction in patients with stable coronary artery disease - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098037
Enrollment
78
Registered
2025-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: Colchicine Group: Based on Inclusion and Exclusion criteria patient will be started on Tab Colchicine 0.5mg once a day along with his/her usual drugs for secondary Coronary Artery Disea

Sponsors

Dr Akshaya Kamalashree
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To measure the effect of Colchicine in reducing hs-CRP levels and preventing major adverse cardiovascular events in patients with stable Coronary Artery DiseaseTimepoint: hsCRP value at baseline, and 90 days after initiation of drug therapy.

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Akshaya Kamalashree

SRM Medical College Hospital and Research Centre

jenniesureshkumar@gmail.com9445686996

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026