Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (NCT05047172) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
United States1,683 participantsStarted 2022-08-02
Plain-language summary
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. diabetes treated with insulin for at least 15 years
. at least 2 of the following atherosclerotic risk factors: hypertension (BP \> 140/90 or on antihypertensive therapy); dyslipidemia (LDL \> 130 mg /dl or HDL \< 40 mg/dl or fasting triglycerides \> 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; any of the following vascular events occurring in a parent or sibling who was \< 55 years of age for men or \< 65 years of age for women at the time of the event: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery for atherosclerotic disease
. personal history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
. any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing anti-coagulation therapy versus anti-platelet therapy for intracranial artery narrowing — can you explain what the real-world difference in bleeding risk might look like for me personally, given that one of the main things being measured is serious hemorrhage including brain bleeds?
2Since the trial is no longer enrolling new participants, does that change my options at all, and should I be looking at other active trials or standard treatments instead?
3The trial is specifically measuring both ischemic stroke and brain hemorrhage as outcomes — given my particular situation, which of those risks do you think is more relevant to me, and how does that affect whether anti-coagulation or anti-platelet therapy might be the right direction?
4How does what we already know about anti-platelet drugs like aspirin or clopidogrel for intracranial artery disease compare to what this trial is trying to find out, and is standard anti-platelet therapy already a proven option I should consider?
5If I were the kind of patient this trial was designed for, what would the day-to-day demands of being on anti-coagulation therapy look like — things like monitoring, diet restrictions, or follow-up visits — and is that realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with parenchymal ICH or non-ICH major hemorrhage
Timeframe: Up to 12 months
2
Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death