1. Protocol: CREST-2 / CREST-H / C2LOE
Title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Sponsor: Mayo Clinic – Jacksonville, FL/University of Maryland
Details: This trial looks at patients with asymptomatic carotid stenosis ≥70%. The study examines the differences between intensive medical management (IMM) only v. procedure (CEA or CAS) in combination with intensive medical management. Subjects will be selected for either CEA or CAS arm of trial, then randomized to either procedure + IMM or IMM alone.
Recently, we were activated for the CREST-2 Long-term Observational Extension, C2LOE, which follows CCREST-2 graduates for another 5 years. Also, we were activated for CREST Hemodynamics (CREST-H), which aims to look at MRA imaging changes throughout a subject’s participation in CREST-2.
Status: Open/Enrolling
Principal Investigator: Dr. Irfan Altafullah
Title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Sponsor: Mayo Clinic – Jacksonville, FL/University of Maryland
Details: This trial looks at patients with asymptomatic carotid stenosis ≥70%. The study examines the differences between intensive medical management (IMM) only v. procedure (CEA or CAS) in combination with intensive medical management. Subjects will be selected for either CEA or CAS arm of trial, then randomized to either procedure + IMM or IMM alone.
Recently, we were activated for the CREST-2 Long-term Observational Extension, C2LOE, which follows CCREST-2 graduates for another 5 years. Also, we were activated for CREST Hemodynamics (CREST-H), which aims to look at MRA imaging changes throughout a subject’s participation in CREST-2.
Status: Open/Enrolling
Principal Investigator: Dr. Irfan Altafullah
Protocol: OCEANIC Stroke – Bayer 20604
Title: A multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, and event-driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA.
Sponsor: Bayer Pharmaceuticals
Details: Using concomitant anti-coagulant therapies, asundexian is proposed to inhibit a key player in the clotting cascade, Factor Xia, while preventing unnecessary bleeding in people who have had a stroke or TIA, and also to prevent such events. Recently, we were activated for the MRI Sub-study which reviews changes in imaging from first visit to last visit.
Status: Open/Enrolling
Principal Investigator: Dr. Irfan Altafullah
Title: A multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, and event-driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA.
Sponsor: Bayer Pharmaceuticals
Details: Using concomitant anti-coagulant therapies, asundexian is proposed to inhibit a key player in the clotting cascade, Factor Xia, while preventing unnecessary bleeding in people who have had a stroke or TIA, and also to prevent such events. Recently, we were activated for the MRI Sub-study which reviews changes in imaging from first visit to last visit.
Status: Open/Enrolling
Principal Investigator: Dr. Irfan Altafullah
Research contact: Irfan Altafullah, MD, Irfan.altafullah@mpls-clinic.com