NCT05175274Not yet recruitingPhase 3
Colchicine Use for Primary Prevention of Coronary Artery Disease
Colchicine Use for Primary Prevention in People at High Risk of Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 21 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Colchicine has been widely used as an anti-gout medicine in the past decades. Some recent clinical trials have proved that low-dose colchicine can be used as a secondary prevention drug for coronary artery disease because of its anti-inflammatory mechanism. However, the effect on primary prevention has not been observed sufficiently. The objective of this study is to determine whether colchicine reduces the incidence of CAD in patients and its safety for long-term use.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 6792 (estimated)
- First submitted
- 14 Dec 2021
- Start date
- 6 Dec 2022
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Qingdao Central Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05175274
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 6792
- From 6 Dec 2022 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 1\. Patients with any pre-existing diagnosis of coronary artery disease.2.Other cardiovascular diseases such as peripheral vascular disease, congestive heart failure and cardiomyopathy.3.Cerebrovascular diseases such as cerebral thrombosis and cerebral hemorrhage. 4.Currently on treatment with colchicine.5.Patients who are known to be allergic to colchicine.6 Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before recruitment.7.Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.8.Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
Who the study is looking for
- 1\. Males and females who have at least 3 risk factors for CAD. 2. GFR\>90mmol/L. 3 People are within 40-70 years old.4. Patients are not pre-diagnosed with CAD, which is defined by negative results of CT coronary angiography.
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mengmei Li Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.