StrokePhase 3NCT07035405
Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX)
A Phase 3 study testing Colchicine 0.5 mg in people with Stroke, run by Beijing Tiantan Hospital.
Trial summary
The role of colchicine in the secondary prevention of ischemic stroke has not been determinded. This multicenter, randomized, double-blind, placebo-controlled, event-driven clinical trial of CHANCE-3 EX was aimed to assess the efficacy and safety of low-dose colchicine versus placebo on reducing the risk of recurrent… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Colchicine 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,500 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2025to 31 Dec 2028
- 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
- An age of 18-80 years old
- Minor-to-moderate ischemic stroke (NIHSS<15 at randomization; confirmed by CT or MRI)
- Within 7-30 days after the most recent qualifying stroke onset
- Informed consent signed
Who cannot join
- Iatrogenic causes (angioplasty or surgery) of stroke
- mRS>3 at randomization
- Known allergy, sensitivity or intolerance to colchicine
- Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea
- Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level > 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing
- A history of cirrhosis, chronic active hepatitis or severe hepatic disease
Show all 17Show fewer
- Impaired hepatic (ALT or AST > three times the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization
- Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) or leucopenia (white blood cell count <3×109/L) at randomization
- Comorbid gout or other indications for colchicine use
- Active infection at randomization (including respiratory tract infection, urinary tract infection, or gastroenteritis)
- Requiring chronic immunosuppressant, glucocorticoid, or nonsteroidal anti-inflammatory drugs therapy (except aspirin) during the study
- Usage of contraindicated medications for colchicine at randomization: moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram, etc) or P-gp inhibitors (cyclosporine)
- Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days
- Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test
- Severe non-cardiovascular comorbidity, active malignant tumors or terminal-stage illnesses, with a life expectancy of less than 2 years
- Clinically significant drug or alcohol abuse in the past year
- Any other conditions deemed unsuitable for participation in this study or inability to complete study procedures, including but not limited to mental disorders, cognitive or emotional impairments, or physical conditions that may compromise compliance with study protocols and follow-up visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX): a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
The role of colchicine in the secondary prevention of ischemic stroke has not been determinded. This multicenter, randomized, double-blind, placebo-controlled, event-driven clinical trial of CHANCE-3 EX was aimed to assess the efficacy and safety of low-dose colchicine versus placebo on reducing the risk of recurrent ischemic stroke, myocardial infarction and vascular death in patients with minor-to-moderate ischemic stroke.
- Conditions
- Stroke
- Being tested
- Colchicine 0.5 mg, Placebo colchicine
- Keywords
- stroke, colchicine, secondary prevention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mgDrug
Oral colchicine will be initiated with a dose of 0.5 mg per day.
Placebo colchicineDrug
Oral placebo colchicine will be initiated with a dose of 0.5 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Group | Experimental | Patients in this arm will receive low-dose colchicine in addition to standard medical care Receives: Drug: Colchicine 0.5 mg |
| Placebo Colchicine Group | Placebo comparator | Patients in this arm will receive placebo colchicine in addition to standard medical care Receives: Drug: Placebo colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Event of ischemic stroke, myocardial infarction and vascular death
The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
Measured: From randomization to occurrence of the first event, with a median follow-up time of 24 months
Secondary outcomes (5)
Ischemic stroke
The descriptive statistics are presented as the number of participants having had ischemic stroke.
Measured: From randomization to event, with a median follow-up time of 24 months.
Myocardial Infarction
The descriptive statistics are presented as the number of participants having had myocardial infarction.
Measured: From randomization to event, with a median follow-up time of 24 months.
Vascular death
The descriptive statistics are presented as the number of participants having had a vascular death.
Measured: From randomization to death, with a median follow-up time of 24 months.
mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year
The descriptive statistics are presented as the number of participants having had mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year.
Measured: At 1 year
mRS shift
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Jul 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Medical Academy of Research and Translation
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Yongjun Wang, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035405
- Sponsor's protocol ID
- CHANCE-3 EX
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for the study, including de-identified individual participant data and a data dictionary defining each field in the set, can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX): a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07035405
- Acronym / sponsor ID
- CHANCE-3 EX
- Conditions
- Stroke
- Keywords
- stroke, colchicine, secondary prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Medical Academy of Research and Translation
- Study start
- 4 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2025 (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.
The role of colchicine in the secondary prevention of ischemic stroke has not been determinded. This multicenter, randomized, double-blind, placebo-controlled, event-driven clinical trial of CHANCE-3 EX was aimed to assess the efficacy and safety of low-dose colchicine versus placebo on reducing the risk of recurrent ischemic stroke, myocardial infarction and vascular death in patients with minor-to-moderate ischemic stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine Group | Experimental | Drug: Colchicine 0.5 mgPatients in this arm will receive low-dose colchicine in addition to standard medical care |
| Placebo Colchicine Group | Placebo comparator | Drug: Placebo colchicinePatients in this arm will receive placebo colchicine in addition to standard medical care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An age of 18-80 years old
- Minor-to-moderate ischemic stroke (NIHSS<15 at randomization; confirmed by CT or MRI)
- Within 7-30 days after the most recent qualifying stroke onset
- Informed consent signed
Key exclusion criteria (17 listed)
- Iatrogenic causes (angioplasty or surgery) of stroke
- mRS>3 at randomization
- Known allergy, sensitivity or intolerance to colchicine
- Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea
- Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level > 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing
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 mgOral colchicine will be initiated with a dose of 0.5 mg per day. | Drug | Colchicine Group |
| Placebo colchicineOral placebo colchicine will be initiated with a dose of 0.5 mg per day. | Drug | Placebo Colchicine Group |
Primary outcome
First Event of ischemic stroke, myocardial infarction and vascular death
Time frame: From randomization to occurrence of the first event, with a median follow-up time of 24 months
The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
5 secondary outcomes
Ischemic stroke
Time frame: From randomization to event, with a median follow-up time of 24 months.
Myocardial Infarction
Time frame: From randomization to event, with a median follow-up time of 24 months.
Vascular death
Time frame: From randomization to death, with a median follow-up time of 24 months.
mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year
Time frame: At 1 year
mRS shift
Time frame: At 1 year
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 27 Jun 2025.
- Individual participant dataSharing planned: Yes. Data collected for the study, including de-identified individual participant data and a data dictionary defining each field in the set, can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Yongjun Wang principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 mg in people with Stroke, run by Beijing Tiantan Hospital.
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 4 inclusion and 17 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jiejie Li, Ph.D (+86-18210895564, neverever1983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Event of ischemic stroke, myocardial infarction and vascular death (time frame: From randomization to occurrence of the first event, with a median follow-up time of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.