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Anti-Coagulant + Anti-Platelet Therapy for Stroke Prevention (CAPTIVA Trial)
CAPTIVA Trial Summary
This trial is testing whether two drugs are better than one at preventing strokes.
CAPTIVA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCAPTIVA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CAPTIVA Trial Design
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Who is running the clinical trial?
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- I have been treating my diabetes with insulin for 15 years or more.I have a narrowed artery due to plaque buildup confirmed by imaging tests.I haven't had major surgery in the last 30 days and don't plan any in the next 90 days.I have plaque in my aortic arch confirmed by imaging tests.I can walk and take care of myself despite some disability.I am between 30 and 80 years old.I have a heart condition that could cause blood clots.I am not on any blood thinners except aspirin, unless it's heparin for DVT prevention in the hospital.I do not have any health conditions that could shorten my life to under a year.I am not taking, nor required to take, strong medication that affects liver enzyme activity during this study.I do not have severe bleeding, liver issues, uncontrolled high blood pressure, or major kidney problems.I have at least 2 risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes, or a family history of early heart disease.I have a specific blood vessel condition in my brain not caused by common diseases.You are able to swallow pills.I have had or plan to have a procedure like stenting for my stroke.I have not had clot-dissolving drugs in the last 24 hours.My neurological symptoms have worsened in the last 24 hours.I have had a brain bleed in the past.I had symptoms or signs of a brain stroke within the last 30 days.I am between 30 and 80 years old.I had symptoms or signs of a brain stroke within the last 30 days.I can walk and take care of myself despite some disability.I have a history of heart or artery procedures due to blocked arteries.You are able to swallow pills.I cannot live on my own due to severe neurological issues.You have a condition like dementia or mental illness that makes it difficult for you to follow the study's instructions consistently.You have a 70-99% stenosis (or flow gap) of a major intracranal artery documented by CTA, MRA, or catheter angiography.I have a brain tumor (not meningioma) or a brain blood vessel problem.I am allergic to aspirin, rivaroxaban, clopidogrel, or ticagrelor.I am scheduled for a procedure to open narrowed arteries in my head and neck.
- Group 1: Experimental Arm: Ticagrelor and Aspirin
- Group 2: Standard of Care Arm: Clopidogrel and Aspirin
- Group 3: Experimental Arm: Rivaroxaban and Aspirin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Risk Factor Management been cleared by the FDA?
"This medical intervention has received a 3 from our analysts at Power. This rating comes from the fact that this is a Phase 3 trial, thus there is both some evidence of efficacy as well as multiple rounds of data affirming its safety."
What is the unique selling point of this clinical trial?
"Risk Factor Management has been under investigation since 2002, with the first clinical trial being sponsored by Sanofi. After the initial study in 2002 that had 413 participants, Risk Factor Management was approved for Phase 3 drug testing. As of now, there are 264 active studies for Risk Factor Management being conducted in 65 countries and 1600 cities."
Are there any eligibility requirements to take part in this clinical research?
"This study, which is looking for 1683 participants, needs subjects that have cerebral atherosclerosis and are between the ages of 30 and 80. Most notably, candidates are required to meet the following criteria: having symptoms or signs associated with an infarct that occurred within the last month, a Modified Rankin score of 4 or less, the ability to swallow pills, be between the ages of 30 and 80, have diabetes that has been treated with insulin for at least 15 years, have any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery,"
Is this research being conducted in several different locations within the city?
"This study is being conducted at 42 different medical centres, with some of the major locations being in Miami, New york, and Cincinnati. To limit travel, you should select the clinical trial site that is closet to your location."
Is this the first time Risk Factor Management has been explored in a scientific setting?
"Risk Factor Management was first researched in 2002 at Institut Curie Hopital. Consequently, there have been 1030 completed trials and 264 active ones as of now. A large quantity of these ongoing trials are situated in Miami, Florida."
What chronic conditions does Risk Factor Management help to alleviate?
"Risk Factor Management has a broad range of applications and can be used to treat everything from pain to myocardial infarction, catarrh, and fractures."
How many test subjects are being allowed into this trial?
"That is accurate. The clinical trial is ongoing, as indicated by the listing on clinicaltrials.gov. The trial was first posted on 6/29/2022 and was most recently edited on 11/2/2022. This study is enrolling 1683 patients at 42 different sites."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- NYP Columbia University Medical Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
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