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The COCOA-PAD II Trial

Study acronym: COCOA-PAD II
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: May 31, 2026 to Dec 31, 2026
    • Study completion date: Jan 31, 2027 to Jun 1, 2027
    v7
  2. Study completion date: Dec 31, 2026 to Jan 31, 2027v6
  3. Eligibility criteria expanded, about 71 wordsv5
  4. Study sites: 1 to 3v4
  5. Primary completion date: Oct 2025 to May 31, 2026
    • Start date: Sep 20, 2021 to Nov 19, 2021
    • Study completion date: Apr 2026 to Dec 31, 2026
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Start date changed from estimate of Apr 2021 to Sep 20, 2021
    • Study sites: 0 to 1
    • Primary completion date: Apr 2025 to Oct 2025
    • Study completion date: Apr 2025 to Apr 2026
    • Secondary endpoints: 7 to 6
    • Study title shortened, about 8 words
    • Eligibility criteria expanded, about 4 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04794530
Lead Sponsor Northwestern University
Collaborators: National Institute on Aging (NIA), University of Minnesota, University of Chicago
Conditions
(from sponsor)		 Peripheral Artery Disease
Related terms Peripheral Arterial Disease
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov