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Anti-inflammatory Agent

Colchicine for Peripheral Arterial Disease

Q: Are researchers actively seeking participants for this study at the moment?

<p>Upon reviewing the information provided on clinicaltrials.gov, it appears that this particular study is not currently seeking participants. The trial was first posted on January 1st, 2024 and was last updated on January 8th, 2024. However, there are currently 191 other active studies actively recruiting patients at this time.</p>

Phase < 1

Waitlist Available

Led By Michael Levin, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic PAD

Require endarterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up femoral endarterectomy (week 4)

Awards & highlights

Study Summary

This trial will test the effects of reducing inflammation in clogged arteries in the leg. Patients will either receive a medication called colchicine or a fake treatment to see how colchicine affects the inflammation

Who is the study for?

This trial is for individuals with Peripheral Arterial Disease who are undergoing femoral endarterectomy. Specific eligibility criteria details were not provided, so interested participants should inquire further to determine if they qualify.Check my eligibility

What is being tested?

The study aims to see if colchicine can reduce inflammation in the arteries of the leg compared to a placebo. Participants will be randomly assigned to receive either colchicine or a dummy pill without any active ingredients.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed, generally, colchicine can cause gastrointestinal issues like diarrhea and nausea, as well as potential risks of muscle pain and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have pain in my legs due to poor blood flow.

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I need surgery to remove plaque from my artery.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ femoral endarterectomy (week 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~femoral endarterectomy (week 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and femoral endarterectomy (week 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

NLRP-3 inflammasome transcripts in femoral artery plaque specimens

Secondary outcome measures

Atherosclerotic plaque macrophage activity

Plasma IL6 and hsCRP levels

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981

Chest pain

Ischemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

Colchicine

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ColchicineExperimental Treatment1 Intervention

Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study.

Group II: PlaceboPlacebo Group1 Intervention

This arm is a matching placebo that will be administered in the same fashion as the experimental arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colchicine

2020

Completed Phase 4

~12140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Doris Duke Charitable FoundationOTHER

61 Previous Clinical Trials

260,062 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,263 Total Patients Enrolled

5 Trials studying Peripheral Arterial Disease

1,378 Patients Enrolled for Peripheral Arterial Disease

Michael Levin, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this study at the moment?

"Upon reviewing the information provided on clinicaltrials.gov, it appears that this particular study is not currently seeking participants. The trial was first posted on January 1st, 2024 and was last updated on January 8th, 2024. However, there are currently 191 other active studies actively recruiting patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

2024. "A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06212271.

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