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Tests treatment safety and results for Coronary Heart Disease
Official title Efficacy and Safety of Colchicine After PCI
ClinicalTrials.gov ID: NCT06472908
What this study is testing
What is Colchicine 0.5 mg?
Colchicine 0.5 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for coronary heart disease.
Also referred to as no other name.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colchicine (0.5 mg/day) was recommended by the U.S. Food and Drug Administration in 2023 for the anti-inflammatory treatment of coronary heart disease (CHD).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- (1) Capable and willing to provide informed consent;
- (2) Age ≥18 and ≤80 years old, regardless of sex;
- (3) Hospitalized patients with CHD requiring PCI;
- (4) Completion of all planned PCI during hospitalization;
- (5) Standardized treatment of coronary artery disease according to national guidelines.
You likely can't join if
- (1) Known allergy to colchicine;
- (2) Colchicine taken within 10 days prior to randomization group;
- (3) Patients currently in cardiogenic shock or hemodynamically unstable;
- (4) Patients with known inflammatory bowel disease or chronic diarrhea;
- (5) Abnormal liver function (ALT\> 3 times the upper limit of normal);
- (6) Abnormal renal function (eGFR\<30mL/min/1.73m2);
See the full eligibility criteria
- (1) Capable and willing to provide informed consent;
- (2) Age ≥18 and ≤80 years old, regardless of sex;
- (3) Hospitalized patients with CHD requiring PCI;
- (4) Completion of all planned PCI during hospitalization;
- (5) Standardized treatment of coronary artery disease according to national guidelines.
- (1) Known allergy to colchicine;
- (2) Colchicine taken within 10 days prior to randomization group;
- (3) Patients currently in cardiogenic shock or hemodynamically unstable;
- (4) Patients with known inflammatory bowel disease or chronic diarrhea;
- (5) Abnormal liver function (ALT\> 3 times the upper limit of normal);
- (6) Abnormal renal function (eGFR\<30mL/min/1.73m2);
- (7) Active malignant tumors reported in past medical history;
- (8) Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;
- (9) Pregnant women, lactating women or women of childbearing age who did not use effective contraceptives;
- (10) Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Lanzhou, Gansu, China
- Wuhan, Hubei, China
- Beijing, China
- Chongqing, China
- Dalian, China
- Enshi, China
- Harbin, China
- Hefei, China
- Huangshi, China
- Jinan, China
- Jingzhou, China
- Shanghai, China
- Shenyang, China
- Shiyan, China
- Suizhou, China
- Taiyuan, China
- Wuhan, China
- Xiamen, China
- Xiangyang, China
- Xianning, China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lanzhou, Gansu, China; Wuhan, Hubei, China; Beijing, China; Chongqing, China; Dalian, China; Enshi, China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.