Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)
Objective
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.
Study Arms
- Experimental: Experimental Arm: Ticagrelor and Aspirin
- Active Comparator: Standard of Care Arm: Clopidogrel and Aspirin
- Experimental: Experimental Arm: Rivaroxaban and Aspirin
Eligibility
- Symptoms or signs of any duration associated with an infarct on brain imaging that occurred within 30 days prior to randomization
- Index infarct is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) documented by CTA, MRA, or catheter angiography
- Modified Rankin score of ≤ 4
- Ability to swallow pills
- Age 30-80 years, inclusive, at time of consent
- Subjects 30-49 years of age are required to meet at least ONE of the following additional criteria below to qualify for the study:
- 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
- aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
- any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic
- Negative pregnancy test in a female who has had any menses in the last 18 months and has not had surgery that would make her unable to become pregnant
- Subject is willing and able to return for all follow-up visits required by the protocol
- Subject is available by phone
- Subject understands the purpose and requirements of the study and can make him/herself understood
- Subject has provided informed consent (use of a LAR is not permitted)
NCT ID
NCT05047172
