Peripheral Artery Disease study: Cocoa flavanols
Official title The COCOA-PAD II Trial
ClinicalTrials.gov ID: NCT04794530
What this study is testing
What is cocoa flavanols?
an investigational oral capsule 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
- The study wants to know whether cocoa flavanols can improve or slow the decline of walking distance measured by a six‑minute walk test over six months.
- Who it's for
- Adults age 55 or older who have peripheral artery disease.
- What's involved
- Participants will be randomly assigned to take a cocoa flavanol supplement or a placebo for six months and will have walking tests and other health measurements during clinic visits.
- Time commitment
- The trial lasts six months and includes several clinic visits for assessments.
- 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
- 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
- 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.
- 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.
- 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 is enrolling
- Chicago, Illinois, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Chicago, Illinois, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.