Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)

Clinical Trial Details

The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin may have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery. This research is important to future patients, as this knowledge may help doctors do a better job of preventing stroke in patients with major narrowing of brain arteries.

One possible treatment that we will be testing in this study is to use different medications to prevent blood clots. The currently accepted standard medications used for preventing blood clots are clopidogrel and aspirin. There are some preliminary studies suggesting that substituting clopidogrel with different medications, such as ticagrelor or rivaroxaban, may lower the risk of having another stroke in the following year but could also cause more bleeding events.

Ticagrelor is approved by the US Food and Drug Administration (FDA) to reduce the risk of another stroke in patients with a recent stroke, and rivaroxaban is also approved by the FDA at a higher dose than is being used in this study to prevent stroke in patients with an irregular heart rhythm called atrial fibrillation, however, it is considered investigational at the dose given in this study.

Participants will be randomized into one of three study treatments: ticagrelor and aspirin, rivaroxaban and aspirin, or clopidogrel and aspirin. The study team will discuss the dosing of each medication with individual participants.

Participants will also receive Intensive Medical Therapy: treatment of their blood pressure, cholesterol, diabetes if they are diabetic, program to stop smoking if they smoke, and program for weight loss if they are obese.

Study visits will be required at the start of the study and at 1-month, 4-months, 8-months, and 12-months. During the initial visit, participants will also have a mouthwash or cheek swab sample collected to look at the makeup of one of their genes.

Total study participation is expected to last approximately 12 months.

Key Eligibility:

Acute focal symptoms or signs of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting greater than or equal to 24 hours that occurred within 30 days.
Index stroke is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, middle cerebral artery (M1 or M2), vertebral artery (V4), basilar artery, posterior cerebral artery (P1), or anterior cerebral artery (A1)) documented by CTA, MRA, or catheter angiography.
At least 30 years of age.
Participants must not have a previous treatment of target lesion with a stent, angioplasty, or other mechanical device, including mechanical thrombectomy for the qualifying stroke, or plan to perform one of these procedures.
Participants must not have a history of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).

Detailed eligibility will be reviewed when you contact the study team.

Return to List

Study contact by location

Upper East Side - Manhattan

Contact(s)

Carla Pisarro Sherman
(212) 746-6538
cas9149@med.cornell.edu

Primary Investigator(s)

Dana Leifer, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2201024288

ClinicalTrials.gov:

NCT05047172

Status

Open to Enrollment

Age Group

Adult

Disease

Stroke