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New treatment option for Peripheral Artery Disease
Official title The COCOA-PAD II Trial
ClinicalTrials.gov ID: NCT04794530
What this study is testing
What is cocoa flavanols?
cocoa flavanols is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Age 55 and older
- Presence of peripheral artery disease (PAD). PAD will be defined as either:
- An ABI \<= 0.90 at baseline.
- 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 angiographic...
- An ABI of \>0.90 and \<=1.00 who experience a a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.
You likely can't join if
- Above- or below-knee amputation
- Critical limb ischemia
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a symptom other than PAD
- Current foot ulcer on bottom of foot
- Failure to successfully complete the one-week study run-in
See the full eligibility criteria
- Age 55 and older
- Presence of peripheral artery disease (PAD). PAD will be defined as either:
- An ABI \<= 0.90 at baseline.
- 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 angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the...
- An ABI of \>0.90 and \<=1.00 who experience a a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.
- Above- or below-knee amputation
- Critical limb ischemia
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a symptom other than PAD
- Current foot ulcer on bottom of foot
- Failure to successfully complete the one-week study run-in
- Planned major surgery, coronary or leg revascularization during the next eight months
- Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
- Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than eight months, or cancer requiring treatment in the previous two years. [NOTE...
- Mini-Mental Status Examination (MMSE) score \< 23
- Allergy to the study intervention
- Potential participants who have taken cocoa supplements in previous three months, are unwilling to avoid taking cocoa flavanol supplements, or are consuming dark chocolate regularly (i.e. approximately 1.5 ounces of...
- Non-English speaking
- Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit...
- Visual impairment that limits walking ability
- Six-minute walk distance of \ 1600 feet.
- Participation in a supervised treadmill exercise program in previous three months
- Unable to tolerate caffeine
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Minneapolis, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.