Ischemic StrokePhase 4COLCHIDANCT06102720
Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization
A Phase 4 study testing Colchicine and Clopidogrel in people with Ischemic Stroke, run by Mikhail Zykov at 2 sites in Russia.
Trial summary
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Colchicine and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesRussia
- Study dates
- 12 Jan 2023to 1 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form by patient prior to any study-specific procedure.
- Patient age over 18 years
- Presence of ipsilateral lesion of the extracranial artery ≥50% according to the European measurement method ECST or its occlusion, as well as stenosis < 50% with signs of morphological instability of the atherosclerotic plaque (ulceration, hemorrhage into the plaque, intimal flotation, mural thrombus, etc.).
- Minor neurological deficit (NIHSS score ≤5).
- The duration of development of stroke symptoms before colchicine taken is no more than 48 hours.
- Confirmation of the presence of a focus of acute ischemia in the brain according to computed tomography or magnetic resonance imaging of the brain.
Who cannot join
- The presence of risk factors and conditions that determine a different pathogenetic subtype of ischemic stroke (atrial fibrillation/flutter, ventricular aneurysm, ets.).
- Hemorrhagic stroke
- NIHSS score ≤5.
- Hospitalization of the patient more than 48 hours from the onset of the disease.
- Severe anemia, thrombocytopenia, leukopenia.
- Course of an infectious/viral disease.
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- Concomitant treatment with moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil or pilitin disulfazole) inhibitors (cyclosporine) at randomization.
- Concomitant severe degenerative disease of the nervous system.
- Concomitant inflammatory or autoimmune disease.
- Dementia, established mental illness.
- History of malignancy, known hepatitis B or C, or HIV infection.
- Swallowing impairment interfering with oral administration of the study drug.
- Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
- Participation in another clinical study with an investigational product at any time during the 30 days prior to randomization
- Previous enrolment or randomization in the present study.
- Decrease renal function with creatinine clearance < 30 ml/min.
- Presence of contraindications to taking colchicine, acetylsalicylic acid and clopidogrel.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Research Institute for Complex Issues of Cardiovascular Diseas
Kemerovo, Kemerovo Oblast, 650002
Mikhail Zykov, PhD, +79183062959, mvz83@mail.ru
- Recruiting
Sochi City Hospital #4
Sochi, Krasnodar Refion, 354057
Mikhail Zykov, PhD, +79183062959, mvz83@mail.ru
Vadim Butsev
About this study
Official title: Two-center, Prospective, Randomized, Open-label, Controlled Clinical Trial With Endpoint Evaluation
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization.
Read the detailed description
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. Patients in one arm will receive colchicine initiated with a dose of 0.5 mg per day during on days 1 through 14. Study visits will be performed on the day of randomization and at discharge. The outcomes were stroke, neurological deterioration, сombined endpoint events (stroke, myocardial infarction and death), bleeding during 14 days of follow-up in an intention-to treat analysis.
- Conditions
- Ischemic Stroke
- Being tested
- Colchicine, Clopidogrel
- Keywords
- ischemic stroke, low-dose colchicine, clopidogrel
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Oral colchicine will be initiated with a dose of 0.5 mg per day during 14 days. Acetylsalicylic acid was used as an antiplatelet agent (300 mg on days 1 and continuing with 100 mg/day).
ClopidogrelDrug
Dual antiplatelet therapy includes ASA (300 mg on days 1 and continuing with 100 mg/day) and clopidogrel (300 mg on days 1 and continuing with 75 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Group | Experimental | All patients in this arm will receive colchicine for 14 days in addition to standard medical care without clopidogrel (acetylsalicylic acid, lipid-lowering, antihypertensive, gastroprotective, hypoglycemic drugs if necessary, lifestyle recommendations, early rehabilitation activities). Receives: Drug: Colchicine |
| Clopidogrel treatment group | Active comparator | All patients in this arm will receive standard treatment including clopidogrel. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any new stroke events
Incidence of any new ischemic stroke.
Measured: any time within 14 days
Neurological deterioration
Neurological deterioration, defined as an increase in The National Institutes of Health Stroke Scale (NIHSS) of 2 or more. The NIHSS provides a quantitative measure of stroke-related neurologic deficit. The higher the score, the more severe the neurological deficit.
Measured: any time within 14 days
Secondary outcomes (3)
New vascular events
Incidence of any new vascular events, including ischemic stroke, myocardial infarction and vascular death
Measured: any time within 14 days
Bleeding event
Bleeding event that is categorised as severe according to GUSTO (Global Utilization Of Streptokinase And Tpa For Occluded Arteries) bleeding criteria.
Measured: any time within 14 days
Positive functional outcome
A positive functional outcome within 14 days is determined if the Modified Rankin Score (mRS) improves to 0-1 and/or Rivermead Mobility Index (RMI) to 14 -15 points and/or Rehabilitation Routing Scale 0 -1 points.
The mRS is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
The RMI includes fifteen mobility items. A maximum score of 15 is possible: higher scores indicate better mobility performance.
The rehabilitation routing scale is needed by the doctor to understand whether the patient requires rehabilitation. The maximum number of points is 6. The more points the patient scores, the more severe his condition.
Measured: any time within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start12 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mikhail Zykov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikhail Zykov, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102720
- Sponsor's protocol ID
- COLCHIDA_1
- Acronym
- COLCHIDA
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-center, Prospective, Randomized, Open-label, Controlled Clinical Trial With Endpoint Evaluation
- ClinicalTrials.gov ID
- NCT06102720
- Acronym / sponsor ID
- COLCHIDA / COLCHIDA_1
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, low-dose colchicine, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mikhail ZykovUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 26 Oct 2023 (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.
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization.
Detailed description
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. Patients in one arm will receive colchicine initiated with a dose of 0.5 mg per day during on days 1 through 14. Study visits will be performed on the day of randomization and at discharge. The outcomes were stroke, neurological deterioration, сombined endpoint events (stroke, myocardial infarction and death), bleeding during 14 days of follow-up in an intention-to treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine Group | Experimental | Drug: ColchicineAll patients in this arm will receive colchicine for 14 days in addition to standard medical care without clopidogrel (acetylsalicylic acid, lipid-lowering, antihypertensive, gastroprotective, hypoglycemic drugs if necessary, lifestyle recommendations, early rehabilitation activities). |
| Clopidogrel treatment group | Active comparator | Drug: ClopidogrelAll patients in this arm will receive standard treatment including clopidogrel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form by patient prior to any study-specific procedure.
- Patient age over 18 years
- Presence of ipsilateral lesion of the extracranial artery ≥50% according to the European measurement method ECST or its occlusion, as well as stenosis < 50% with signs of morphological instability of the atherosclerotic plaque (ulceration, hemorrhage into the plaque, intimal flotation, mural thrombus, etc.).
- Minor neurological deficit (NIHSS score ≤5).
- The duration of development of stroke symptoms before colchicine taken is no more than 48 hours.
Key exclusion criteria (17 listed)
- The presence of risk factors and conditions that determine a different pathogenetic subtype of ischemic stroke (atrial fibrillation/flutter, ventricular aneurysm, ets.).
- Hemorrhagic stroke
- NIHSS score ≤5.
- Hospitalization of the patient more than 48 hours from the onset of the disease.
- Severe anemia, thrombocytopenia, leukopenia.
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 |
|---|---|---|
| ColchicineOral colchicine will be initiated with a dose of 0.5 mg per day during 14 days. Acetylsalicylic acid was used as an antiplatelet agent (300 mg on days 1 and continuing with 100 mg/day). | Drug | Colchicine Group |
| ClopidogrelDual antiplatelet therapy includes ASA (300 mg on days 1 and continuing with 100 mg/day) and clopidogrel (300 mg on days 1 and continuing with 75 mg/day). | Drug | Clopidogrel treatment group |
Primary outcome
Any new stroke events
Time frame: any time within 14 days
Incidence of any new ischemic stroke.
Neurological deterioration
Time frame: any time within 14 days
Neurological deterioration, defined as an increase in The National Institutes of Health Stroke Scale (NIHSS) of 2 or more. The NIHSS provides a quantitative measure of stroke-related neurologic deficit. The higher the score, the more severe the neurological deficit.
3 secondary outcomes
New vascular events
Time frame: any time within 14 days
Bleeding event
Time frame: any time within 14 days
Positive functional outcome
Time frame: any time within 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Research Institute for Complex Issues of Cardiovascular Diseas
Kemerovo, Russia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine and Clopidogrel in people with Ischemic Stroke, run by Mikhail Zykov at 2 sites in Russia.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any new stroke events (time frame: any time within 14 days). The study lists 2 primary outcomes in all. 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 7 Nov 2023.