Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic… (NCT06102720) | Clinical Trial Compass
UnknownPhase 4
Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization
Russia200 participantsStarted 2023-01-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕. 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.