The COCOA-PAD II Trial
Recruiting
Phase 3
Interventional Study
Peripheral Artery Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 55 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 190 (estimated)
- Sponsor
- Northwestern University · Other
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About This 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. The study will randomize 190 participants with PAD age 55 and older to one of two groups for six m…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 55 and older
2. Presence of peripheral artery disease (PAD). PAD will be defined as either:
1. An ABI \<= 0.90 at baseline.
2. Vascular lab evidence of PAD (such as a toe brachial pressure \< 0.70 or an ankle brachial index less than or equal to 0.90), or angiograp…
Contacts