Colchicine for Intracranial Hemorrhage

(CoVasc-ICH Trial)

Recruiting at 11 trial locations

Overseen By Kevin W Reeh, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Population Health Research Institute

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Inflammatory bowel disease, Cirrhosis, Renal insufficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to test if colchicine, an anti-inflammatory medication, can safely prevent heart and brain damage in patients who have had a stroke caused by brain bleeding. Colchicine has been studied for its potential to reduce the incidence of postoperative atrial fibrillation and has shown some effectiveness in reducing inflammation.

Research Team

Aristeidis Katsanos, MD

Principal Investigator

Population Health Research Institute

Ashkan Shoamanesh, MD

Principal Investigator

Population Health Research Institute

Eligibility Criteria

This trial is for individuals who've had a spontaneous brain bleed within the last 48 hours and can consent to participate. It's not for those with ICH due to trauma, liver issues, or on certain drugs that interact badly with colchicine. Pregnant women and people unlikely to follow the study plan or live less than six months are also excluded.

Inclusion Criteria

I can sign the consent form myself or have someone legally allowed to do it for me.

I had a stroke caused by bleeding in the brain within the last 2 days.

Exclusion Criteria

My brain bleed is not due to injury, abnormal blood vessels, tumors, or bleeding disorders.

I have severe liver problems or cirrhosis.

I am not taking strong CYP3A4 or P-gp inhibitors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral colchicine 0.5mg or placebo once daily

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Colchicine

Trial Overview The CoVasc-ICH trial tests if colchicine can prevent heart problems and further brain injury after a brain hemorrhage. Participants will either receive colchicine pills or a placebo, without knowing which one they're getting, to compare outcomes effectively.

Participant Groups

Group I: Oral Colchicine, 0.5mg once daily Experimental Treatment 1 Intervention

Active colchicine tablet

Group II: Oral matching placebo, once daily Placebo Group 1 Intervention

Matching placebo tablet

Colchicine is already approved in United States for the following indications:

Approved in United States as Colcrys for:

• Gout
• Familial Mediterranean Fever

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+