Coronary Heart DiseasePhase 3NCT06472908
Efficacy and Safety of Colchicine After PCI
A Phase 3 study testing Colchicine 0.5 mg and Colchicine 0.375 mg in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 36 sites in China.
Trial summary
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). However, colchicine is still not approved for CHD treatment in China. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention, Colchicine
- What is being tested?
- Colchicine 0.5 mg and Colchicine 0.375 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,862 participants
- Where
- 36 sitesChina
- Study dates
- 9 Jul 2024to 31 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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);
Show all 10Show fewer
- (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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
China36 sites
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, Hubei
The First Affiliated Hospital of Harbin Medical University
Harbin, Harbin
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Huangshi Central Hospital
Huangshi, Hubei
Shandong Provincial Hospital
Jinan, Shandong
Jingzhou Central Hospital
Jingzhou, Hubei
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, Liaoning
Dongfeng General Hospital, Hubei University of Medicine
Shiyan, Hubei
Shiyan Renmin Hospital
Shiyan, Hubei
Taihe hospital
Shiyan, Hubei
Suizhou Central Hospital
Suizhou, Hubei
Shanxi Cardiovascular Disease Hospital
Taiyuan, Shanxi
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
China Resources and WISCO General Hospital
Wuhan, Hubei
Fifth Hospital in Wuhan
Wuhan, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei
Wuhan Central Hospital
Wuhan, Hubei
Wuhan First Hospital
Wuhan, Hubei
Wuhan Fourth Hospital
Wuhan, Hubei
Wuhan Puren Hospital
Wuhan, Hubei
Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University
Wuhan, Hubei
Wuhan Third Hospital
Wuhan, Hubei
Wuhan Wuchang Hospital
Wuhan, Hubei
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Xiangyang Central Hospital
Xiangyang, Hubei
Xiangyang First People's Hospital
Xiangyang, Hubei
Xianning Central Hospital
Xianning, Hubei
Yichang Central People's Hospital
Yichang, Hubei
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan
About this study
Official title: Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention
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). However, colchicine is still not approved for CHD treatment in China. There is no large-scale clinical evidence that colchicine can be used to treat Chinese patients with CHD. Considering the low body weight of the East Asian population, it is unclear whether the recommended standard dose (0.5 mg/day) is suitable for Chinese patients. Therefore, we need to further explore the effects of different doses of colchicine on the efficacy and safety of clinical endpoints in the Chinese population with CHD.
This study is a multicenter, prospective, randomized, controlled, double-blind, event-driven clinical study conducted in China. The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI. The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population.
Read the detailed description
After informed consent, 8862 subjects who meet all inclusion will be randomly assigned to receive colchicine (0.5 mg/day), colchicine (0.375 mg/day), or placebo (1:1:1 allocation ratio), with follow-up at months (1, 6, 12, 18, 24…) after randomization, and phone assessments at months (3, 9, 15, 21…). The occurrence of any endpoints or other adverse events will be assessed every 3 months. Subjects will also receive standard medical care for antiplatelets, control of dyslipidemia, hypertension, angina and diabetes as directed by national guidelines. All suspected cardiovascular endpoints will be adjudicated by the Clinical Event Committee (CEC, consisting of three experienced members blinded as to allocation of therapy). The Data and Safety Monitoring Board (DSMB, consisting of five fully independent members) will review unblinded safety data as detailed in the DSMB charter. An interim analysis is planned after approximately 50% of primary endpoints have been positively adjudicated. The DSMB charter will pre-specify the methodology for the interim analysis and the rules for early termination of the study.
- Being tested
- Colchicine 0.5 mg, Colchicine 0.375 mg, Placebo
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mgDrug
Also called no other name
Colchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mgDrug
Also called no other name
Colchicine 0.375 mg, one pill a day, oral intake
PlaceboDrug
Also called no other name
Placebo, one pill a day, oral intake
| Study group | Role | What they receive |
|---|---|---|
| Colchicine 0.5 mg | Experimental | Colchicine 0.5 mg, one pill a day, oral intake Receives: Drug: Colchicine 0.5 mg |
| Colchicine 0.375 mg | Experimental | Colchicine 0.375 mg, one pill a day, oral intake Receives: Drug: Colchicine 0.375 mg |
| Placebo | Placebo comparator | Placebo, one pill a day, oral intake Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization
From randomization to the first occurrence
Measured: An estimated 2-4 years period
Secondary outcomes (9)
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
From randomization to the first occurrence
Measured: An estimated 2-4 years period
Ischemia-driven revascularization
The number of participants with Ischemia-driven revascularization
Measured: An estimated 2-4 years period
Nonfatal myocardial infarction
The number of participants with myocardial infarction
Measured: An estimated 2-4 years period
Nonfatal stroke
The number of participants with stroke
Measured: An estimated 2-4 years period
Urgent hospitalization for unstable angina
The number of participants with urgent hospitalization for unstable angina
Measured: An estimated 2-4 years period
In-stent restenosis
The number of participants with in-stent restenosis
Measured: An estimated 2-4 years period
Stent thrombosis
The number of participants with stent thrombosis
Measured: An estimated 2-4 years period
Cardiovascular death
The number of participants with cardiovascular death
Measured: An estimated 2-4 years period
All-cause mortality
The number of participants with all-cause death
Measured: An estimated 2-4 years period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start9 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,862 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiang Cheng, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472908
- Sponsor's protocol ID
- COLPCI
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lawler PR, Bhatt DL, Godoy LC, Luscher TF, Bonow RO, Verma S, Ridker PM. Targeting cardiovascular inflammation: next steps in clinical translation. Eur Heart J. 2021 Jan 1;42(1):113-131. doi: 10.1093/eurheartj/ehaa099.
PubMed 32176778Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.
PubMed 37558377Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.
PubMed 33769515
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06472908
- Acronym / sponsor ID
- COLPCI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,862 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). However, colchicine is still not approved for CHD treatment in China. There is no large-scale clinical evidence that colchicine can be used to treat Chinese patients with CHD. Considering the low body weight of the East Asian population, it is unclear whether the recommended standard dose (0.5 mg/day) is suitable for Chinese patients. Therefore, we need to further explore the effects of different doses of colchicine on the efficacy and safety of clinical endpoints in the Chinese population with CHD.
This study is a multicenter, prospective, randomized, controlled, double-blind, event-driven clinical study conducted in China. The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI. The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population.
Detailed description
After informed consent, 8862 subjects who meet all inclusion will be randomly assigned to receive colchicine (0.5 mg/day), colchicine (0.375 mg/day), or placebo (1:1:1 allocation ratio), with follow-up at months (1, 6, 12, 18, 24…) after randomization, and phone assessments at months (3, 9, 15, 21…). The occurrence of any endpoints or other adverse events will be assessed every 3 months. Subjects will also receive standard medical care for antiplatelets, control of dyslipidemia, hypertension, angina and diabetes as directed by national guidelines. All suspected cardiovascular endpoints will be adjudicated by the Clinical Event Committee (CEC, consisting of three experienced members blinded as to allocation of therapy). The Data and Safety Monitoring Board (DSMB, consisting of five fully independent members) will review unblinded safety data as detailed in the DSMB charter. An interim analysis is planned after approximately 50% of primary endpoints have been positively adjudicated. The DSMB charter will pre-specify the methodology for the interim analysis and the rules for early termination of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colchicine 0.5 mg | Experimental | Drug: Colchicine 0.5 mgColchicine 0.5 mg, one pill a day, oral intake |
| Colchicine 0.375 mg | Experimental | Drug: Colchicine 0.375 mgColchicine 0.375 mg, one pill a day, oral intake |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, one pill a day, oral intake |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (10 listed)
- (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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 mgAlso: no other nameColchicine 0.5 mg, one pill a day, oral intake | Drug | Colchicine 0.5 mg |
| Colchicine 0.375 mgAlso: no other nameColchicine 0.375 mg, one pill a day, oral intake | Drug | Colchicine 0.375 mg |
| PlaceboAlso: no other namePlacebo, one pill a day, oral intake | Drug | Placebo |
Primary outcome
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization
Time frame: An estimated 2-4 years period
From randomization to the first occurrence
9 secondary outcomes
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Time frame: An estimated 2-4 years period
Ischemia-driven revascularization
Time frame: An estimated 2-4 years period
Nonfatal myocardial infarction
Time frame: An estimated 2-4 years period
Nonfatal stroke
Time frame: An estimated 2-4 years period
Urgent hospitalization for unstable angina
Time frame: An estimated 2-4 years period
In-stent restenosis
Time frame: An estimated 2-4 years period
Stent thrombosis
Time frame: An estimated 2-4 years period
Cardiovascular death
Time frame: An estimated 2-4 years period
All-cause mortality
Time frame: An estimated 2-4 years period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Results publication: PubMed 32176778Lawler PR, Bhatt DL, Godoy LC, Luscher TF, Bonow RO, Verma S, Ridker PM. Targeting cardiovascular inflammation: next steps in clinical translation. Eur Heart J. 2021 Jan 1;42(1):113-131. doi: 10.1093/eurheartj/ehaa099.
- Results publication: PubMed 37558377Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.
- Results publication: PubMed 33769515Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Cheng, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 mg and Colchicine 0.375 mg in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 36 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization (time frame: An estimated 2-4 years period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06472908, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.