Ischemic Stroke Clinical Trial
— COLCHIDAOfficial 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Signed informed consent form by patient prior to any study-specific procedure. 2. Patient age over 18 years 3. 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.). 4. Minor neurological deficit (NIHSS score =5). 5. The duration of development of stroke symptoms before colchicine taken is no more than 48 hours. 6. Confirmation of the presence of a focus of acute ischemia in the brain according to computed tomography or magnetic resonance imaging of the brain. Exclusion Criteria: 1. The presence of risk factors and conditions that determine a different pathogenetic subtype of ischemic stroke (atrial fibrillation/flutter, ventricular aneurysm, ets.). 2. Hemorrhagic stroke 3. NIHSS score =5. 4. Hospitalization of the patient more than 48 hours from the onset of the disease. 5. Severe anemia, thrombocytopenia, leukopenia. 6. Course of an infectious/viral disease. 7. 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. 8. Concomitant severe degenerative disease of the nervous system. 9. Concomitant inflammatory or autoimmune disease. 10. Dementia, established mental illness. 11. History of malignancy, known hepatitis B or C, or HIV infection. 12. Swallowing impairment interfering with oral administration of the study drug. 13. 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. 14. Participation in another clinical study with an investigational product at any time during the 30 days prior to randomization 15. Previous enrolment or randomization in the present study. 16. Decrease renal function with creatinine clearance < 30 ml/min. 17. Presence of contraindications to taking colchicine, acetylsalicylic acid and clopidogrel. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Institute for Complex Issues of Cardiovascular Diseas | Kemerovo | Kemerovo Region |
Russian Federation | Sochi City Hospital #4 | Sochi | Krasnodar Refion |
Lead Sponsor | Collaborator |
---|---|
Mikhail Zykov |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Any new stroke events | Incidence of any new ischemic stroke. | any time within 14 days | |
Primary | 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. | any time within 14 days | |
Secondary | New vascular events | Incidence of any new vascular events, including ischemic stroke, myocardial infarction and vascular death | any time within 14 days | |
Secondary | Bleeding event | Bleeding event that is categorised as severe according to GUSTO (Global Utilization Of Streptokinase And Tpa For Occluded Arteries) bleeding criteria. | any time within 14 days | |
Secondary | 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. |
any time within 14 days |
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