Status:
UNKNOWN
Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization
Lead Sponsor:
Mikhail Zykov
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06102720
Start Date
January 12 2023
End Date
February 1 2025
Last Update
November 7 2023
Active Locations (2)
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1
Research Institute for Complex Issues of Cardiovascular Diseas
Kemerovo, Kemerovo Oblast, Russia, 650002
2
Sochi City Hospital #4
Sochi, Krasnodar Refion, Russia, 354057