NCT06078904CompletedPhase 4
Different Doses of Colchicine on hsCRP
The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
Source: ClinicalTrials.gov · Last updated 16 Apr 2024
Brief summary (registry, in English)
Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 5 Oct 2023
- Start date
- 10 Oct 2023
- Primary completion date
- 25 Dec 2023
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Coronary artery disease
- NCT number
- NCT06078904
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 200
- From 10 Oct 2023 to the primary completion date, 25 Dec 2023
- 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.
Prior treatment
- Colchicine was taken within 10 days before randomization;
- Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs;
Other illness
- Known allergies to colchicine;
- Uncontrolled infectious diseases;
- Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc;
Lab values
- Abnormal renal function test (eGFR\<30mL/min);
- Thrombocytopenia (platelet count \<100 g/L);
Age
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
Other
- Abnormal liver function test (alanine aminotransferase \>3 times the upper limit of normal value);
- Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
Who the study is looking for
- Volunteer to participate, understand and sign an informed consent form;
- Age ≥ 18 years old, regardless of gender;
- Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;
- Complete all planned percutaneous coronary intervention during hospitalization;
- Patient must be treated according to national guidelines for standard treatment of coronary heart disease.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.