<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>13825</id><no>CAPTIVA-NCT05047172</no><status>Open</status><title>CAPTIVA is a two-stage Phase III trial randomizing subjects&#xD;
with stroke attributed to 70-99% intracranial atherosclerotic &#xD;
stenosis (sICAS) to:&#xD;
1) ticagrelor + aspirin&#xD;
2) low dose rivaroxaban + aspirin&#xD;
3) clopidogrel + aspirin&#xD;
The primary goal of the trial is to determine if the&#xD;
experimental arm(s) (rivaroxaban or ticagrelor or both) are&#xD;
superior to the clopidogrel arm for lowering the 1-year rate of&#xD;
the primary endpoint (ischemic stroke, intracerebral&#xD;
hemorrhage (ICH), or vascular death).&#xD;
The first stage of the trial is concluded by an interim safety &#xD;
analysis intended to identify an excess of parenchymal&#xD;
intracerebral hemorrhage (ICH) or non-ICH major&#xD;
hemorrhage with ticagrelor + aspirin or low dose rivaroxaban&#xD;
+ aspirin that could lead to an early termination of one or both&#xD;
of those arms.&#xD;
The second stage of the trial will determine if the&#xD;
experimental arm(s) (rivaroxaban or ticagrelor or both) that&#xD;
progress to stage 2 are superior to the clopidogrel arm for&#xD;
lowering the 1-year rate of the primary endpoint (ischemic&#xD;
stroke, intracerebral hemorrhage (ICH), or vascular death).&#xD;
An exploratory aim is to estimate the impact of CYP2C19&#xD;
loss-of-function (LOF) carrier status on any benefit that the&#xD;
ticagrelor or low dose rivaroxaban arms may have in lowering&#xD;
the primary endpoint compared with the clopidogrel arm.</title><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.&#xD;
</objective><nct_id>NCT05047172</nct_id><sponsor_type>Externally Peer-Reviewed; National</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><treatment>Drug: Ticagrelor + Aspirin&#xD;
Drug: Rivaroxaban + Aspirin&#xD;
Drug: Clopidogrel + Aspirin&#xD;
Other: Risk Factor Management</treatment><phase>III</phase><scope>National</scope><disease_site>Diseases Of The Nervous System</disease_site><lay_description>Intracranial Arteriosclerosis&#xD;
Stroke</lay_description><PI>Somani, Sana</PI><institution>Medstar Washington Hospital Center</institution><management_group>MedStar Neuroscience &amp; Rehab Research Network</management_group><item><contact_id>16961</contact_id><item_description>Meselu Amare</item_description><js_safe_str>Meselu Amare</js_safe_str><email>meselu.b.amare@medstar.net</email></item></protocol><sipVersion>2026.1.0 Build 16</sipVersion><copyright> &lt;a href="https://advarra.com" target="_blank"&gt;&amp;copy; 2026 Advarra, Inc.&lt;/a&gt; </copyright></protocol_summary>