Brief Summary

This study is a multicentre, randomized, double-blind, placebo-controlled, investigator-sponsored study that aims to investigate the efficacy of colchicine in preventing recurrent stroke in the patients with acute minor-to-moderate ischemic stroke or TIA and a hsCRP level of ≥2mg/L.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

8,343

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2022

Geographic Reach

1 country

244 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

June 20, 2022

Completed

10 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed

1 month until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2024

Completed

Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

June 20, 2022

Last Update Submit

June 24, 2024

Conditions

Ischemic Stroke TIA

Outcome Measures

Primary Outcomes (1)

Any new stroke events
Incidence of any new ischemic or hemorrhagic stroke
any time within 90 days

Secondary Outcomes (5)

New vascular events
any time within 90 days
New ischemic stroke
any time within 90 days
Poor functional outcome
at 90 days after randomization
New stroke and TIA
any time within 90 days
Severity of recurrent stroke and TIA
within 90 days after randomization

Other Outcomes (11)

Any new stroke events
any time within 1 year after randomization
New vascular events
any time within 1 year after randomization
New ischemic stroke
any time within 1 year after randomization
+8 more other outcomes

Study Arms (2)

Colchicine Group

EXPERIMENTAL

Patients in this arm will receive colchicine for 90 days in addition to standard medical care

Drug: Colchicine

Placebo Colchicine Group

PLACEBO COMPARATOR

Patients in this arm will receive placebo colchicine for 90 days in addition to standard medical care

Drug: Placebo colchicine

Interventions

ColchicineDRUG

Oral colchicine will be initiated with a dose of 1mg per day (one tablet of 0.5mg initially followed by another tablet of 0.5 mg at least four hours later) on days 1 through 3, and continuing with 0.5 mg (one tablet) per day on days 4 through 90.

Colchicine Group

Placebo colchicineDRUG

Oral placebo colchicine will be initiated with a dose of 1mg per day (one tablet of 0.5mg initially followed by another tablet of 0.5 mg at least four hours later) on days 1 through 3, and continuing with 0.5 mg (one tablet) per day on days 4 through 90.

Placebo Colchicine Group

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years or older than 40 years；
Acute cerebral ischemic event due to： Acute minor-to-moderate ischemic stroke (NIHSS≤5 at the time of randomization) or TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 4 at the time of randomization)；
With a hsCRP level of ≥2mg/L at randomization;
Can be treated with study drug within 24 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle)；
Informed consent signed.

You may not qualify if:

Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
Iatrogenic causes (angioplasty or surgery) of stroke or TIA.
Presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve).
A score of ≥ 2 on the modified Rankin scale immediately before the occurrence of the index event.
Usage of colchicine within 30 days before randomization or planning to take colchicine therapy for other indications.
Known allergy or sensitivity or intolerance to colchicine.
Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea.
Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level \> 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing.
A history of cirrhosis, chronic active hepatitis or severe hepatic disease.
Impaired hepatic (ALT or AST \> twice the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization.
Anemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×109/L) or leucopenia (white blood cell \<3×109/L) at randomization.
In the acute phase of respiratory tract infection, urinary tract infection, and gastro-enteritis, or currently using or planning to receive oral or intravenous anti-infective therapy for any other infection.
Currently using or planning to begin long-term (\>7 days) systemic anti-inflammatory drugs (NSAIDs except for aspirin, oral or intravenous steroid therapy) during the study.
Planning to use moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram, etc) or P-gp inhibitors (cyclosporine) at randomization.
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Beijing Tiantan Hospitallead

Study Sites (244)

Linquan County People's Hospital

Fuyang, Anhui, China

Location

Huangshan City People's Hospital

Huangshan City, Anhui, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

The First People's Hospital of Wuhu

Wuhu, Anhui, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Beijing Shunyi Airport Hospital

Beijing, Beijing Municipality, China

Location

Beijing Shunyi Hospital

Beijing, Beijing Municipality, China

Location

Fuxing Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Hospital of Fangshan District, Beijing

Beijing, Beijing Municipality, China

Location

Chongqing Sanbo Chang 'an Hospital