Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization

NCT ID: NCT06102720

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2025-02-01

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 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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colchicine Group

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).

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

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).

Clopidogrel treatment group

All patients in this arm will receive standard treatment including clopidogrel.

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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).

Interventions

Colchicine

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).

Intervention Type: DRUG

Clopidogrel

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mikhail Zykov

OTHER

Sponsor Role: lead

Responsible Party

Mikhail Zykov

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Research Institute for Complex Issues of Cardiovascular Diseas

Kemerovo, Kemerovo Oblast, Russia

Site Status: RECRUITING

Sochi City Hospital #4

Sochi, Krasnodar Refion, Russia

Site Status: RECRUITING

Countries

Russia

Facility Contacts

Mikhail Zykov, PhD

Role: primary

mvz83@mail.ru

+79183062959

Mikhail Zykov, PhD

Role: primary

mvz83@mail.ru

+79183062959

Other Identifiers

COLCHIDA_1

Identifier Type: -

Identifier Source: org_study_id