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NCT04774159 · ClinicalTrials.gov registry record · Phase 3

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

A Phase 3 study of Inflammation and Peripheral Arterial Disease, sponsored by Population Health Research Institute.

Recruiting
Registry status
Phase 3
Development phase
6,150
Enrollment target
20
Study locations

NCT04774159 is a Phase 3 study of Inflammation and Peripheral Arterial Disease that is actively recruiting participants, run by Population Health Research Institute. The registered enrollment target is 6,150 participants, above the 242-participant average among 132 other Inflammation trials with a reported enrollment target (2441% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT04774159, a Phase 3 study of Inflammation and Peripheral Arterial Disease, is actively recruiting participants, sponsored by Population Health Research Institute.

RECRUITING
Registry status
Phase 3
Development phase
6,150 participants
Enrollment target
20
Study locations

Study Summary

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Interventions

  • DRUG Colchicine 0.5 MG Oral Tablet
  • DRUG Colchicine-Placebo

Study Locations (20)

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill
  • Duke Regional Hospital - Durham
  • Duke University Medical Center - Durham
  • Duke Raleigh Hospital - Raleigh

Texas

  • Southwest Family Medicine - Dallas
  • University of Texas Southwestern Medical Center - Dallas
  • Texas Tech University Health Sciences - Lubbock

Florida

  • University of Florida - Gainesville - Gainesville
  • Tampa General Hospital - Tampa

Other

  • Universitair Ziekenhuis Leuven - Leuven
  • Sociedade Hospitalar Angelina Caron - Campina Grande do Sul

Connecticut

  • Yale School of Medicine - New Haven

Illinois

  • University of Chicago Medical Center - Chicago

Michigan

  • Henry Ford Health System - Detroit

New Jersey

  • Rutgers University - Newark

Trial Details

FieldValue
Enrollment Target 6,150 participants
Start Date 2021-05-06
Est. Completion 2029-12
Phase Phase 3

What the Registry Record Tells You About NCT04774159

The ClinicalTrials.gov registry entry for NCT04774159 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 6,150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 242-participant average among 132 other Inflammation trials with a reported enrollment target (2441% higher). The listed sponsor is Population Health Research Institute, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Inflammation appearing as the primary indexed condition, and to 2 interventions - of which Colchicine 0.5 MG Oral Tablet is the first listed.

NCT04774159 reports 20 study locations spanning 13 distinct geographic areas - top geographies include North Carolina, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT04774159 about?

NCT04774159 is a clinical study titled "Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk". The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

What is the current status of trial NCT04774159?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 6,150 participants. The study started on 2021-05-06. Estimated completion is 2029-12.

What conditions does trial NCT04774159 study?

This clinical trial studies the following conditions: Inflammation, Peripheral Arterial Disease, Atherosclerosis of Extremities.

What interventions are being tested in trial NCT04774159?

The interventions under investigation include: Colchicine 0.5 MG Oral Tablet (DRUG), Colchicine-Placebo (DRUG).

Who is sponsoring clinical trial NCT04774159?

This trial is sponsored by Population Health Research Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04774159 being conducted?

This trial has 20 study locations across Connecticut, Florida, Illinois, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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