NCT05047172

Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,683 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is relevant to public health because narrowing of brain arteries is one of the most common causes of stroke worldwide. Compelling evidence suggests novel antithrombotic medications could reduce the rate of stroke in patients with narrowed brain arteries. The proposed study will directly compare novel antithrombotic medications to standard care antiplatelet medications for preventing stroke and death from vascular causes in patients with narrowed brain arteries.

Conditions

• Intracranial Arteriosclerosis
• Stroke

Interventions

Type	Name	Description
DRUG	Ticagrelor + Aspirin	ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
DRUG	Rivaroxaban + Aspirin	low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
DRUG	Clopidogrel + Aspirin	clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
OTHER	Risk Factor Management	Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.

Timeline

• Start date: 2022-08-02
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2021-09-17
• Last updated: 2026-04-15

Locations

117 sites across 1 country: United States

Regulatory

• FDA-regulated drug study