CAPTIVA

(2023)

Objective

Compare the efficacy and safety of three dual antithrombotic regimens in preventing recurrent stroke, intracerebral hemorrhage, or vascular death in patients with symptomatic intracranial atherosclerotic disease (ICAD).

Study Summary

• The CAPTIVA trial is evaluating whether ticagrelor plus aspirin or low-dose rivaroxaban plus aspirin are superior to clopidogrel plus aspirin in reducing the risk of recurrent stroke or vascular events in patients with recent symptomatic ICAD. The trial also incorporates CYP2C19 genotyping to assess clopidogrel metabolism and treatment response.

Intervention

Phase III, double-blind, randomized controlled trial enrolling 1,683 patients with 70–99% symptomatic intracranial stenosis. Patients randomized within 30 days of stroke or TIA to one of three 12-month treatment arms: 1. Ticagrelor 90 mg BID + aspirin 81 mg daily 2. Rivaroxaban 2.5 mg BID + aspirin 81 mg daily 3. Clopidogrel 75 mg daily + aspirin 81 mg daily (control) All patients receive risk factor management and lifestyle coaching.

Study Design

Arms: Ticagrelor 90mg BID + aspirin vs Rivaroxaban 2.5mg BID + aspirin vs Clopidogrel 75mg + aspirin (3-arm)

Outcome

• Primary endpoint: composite of ischemic stroke, intracerebral hemorrhage, or vascular death at 12 months
• Secondary endpoints include: major hemorrhage, individual vascular event rates, safety outcomes, and treatment effect stratified by CYP2C19 genotype
• Results are pending; trial is ongoing with broad site participation across North America

Trial not found