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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: Recruiting Phase 3 study of Inflammation and Peripheral Arterial Disease, sponsored by Population Health Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 6,150 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT04774159 shows while recruiting
NCT04774159 is an interventional study that assigns participants to a tested intervention. Its 6,150 participants enrollment target places it among the larger protocols in the corpus, above the 242-participant average among 132 other Inflammation trials with a reported enrollment target (2441% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT04774159's enrollment target sits among peer trials
6,150 2nd of 132 the highest of 132 other Inflammation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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