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NCT04794530 · ClinicalTrials.gov registry record · Phase 3
The COCOA-PAD II Trial
A Phase 3 study of Peripheral Artery Disease, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
- 3
- Study locations
NCT04794530: Recruiting Phase 3 study of Peripheral Artery Disease, sponsored by Northwestern University.
NCT04794530 is a Phase 3 study of Peripheral Artery Disease that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 190 participants, above the 123-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (54% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04794530, a Phase 3 study of Peripheral Artery Disease, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
- 3
- Study locations
Study Summary
Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 190 participants with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Actigraph-measured physical activity, brachial artery flow-mediated dilation (FMD), gastrocnemius muscle biopsy measures of endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, gastrocnemius muscle perfusion (measured by magnetic resonance imaging (MRI)) and gastrocnemius muscle characteristics (measured by muscle biopsy). To achieve the specific aims, the study will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for six months.
Primary Outcome
Change in six-minute walk distance at six-month follow-up will be compared between those randomized to cocoa flavanols vs. those randomized to placebo.
Conditions Studied
Interventions
- DRUG placebo
- DRUG cocoa flavanols
Study Locations (3)
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2021-11-19 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 3 |
What NCT04794530 shows while recruiting
NCT04794530 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (54% higher).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT04794530 reports a single indexed study location in Illinois, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04794530 about?
NCT04794530 is a clinical study titled "The COCOA-PAD II Trial". Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo...
What is the current status of trial NCT04794530?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2021-11-19. Estimated completion is 2027-01-31.
What conditions does trial NCT04794530 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT04794530?
The interventions under investigation include: placebo (DRUG), cocoa flavanols (DRUG).
Who is sponsoring clinical trial NCT04794530?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04794530 being conducted?
This trial has 3 study locations across Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04794530's enrollment target sits among peer trials
190 16th of 50 higher than 35 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease 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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