Purpose of this Study
We are doing this study to compare different approaches aimed at preventing strokes for people who have already had a stroke. We want to know what combination of drugs seems to have the best outcomes when it comes to stroke prevention.
Who Can Participate?
Eligibility
Adults ages 30-49 who have had a stroke caused by a narrowed blood vessel and meet at least one of the following criteria:<ul>
<li>Are diagnosed with diabetes and have used insulin for at least 15 years</li>
<li>Have 2 of the following risk factors for atherosclerotic disease: hypertension (high blood pressure), dyslipidemia (LDL cholesterol > 130 mg/dl, HDL cholesterol < 40 mg/dl, triglycerides > 150 mg/dl, or using a cholesterol-lowering medicine), or are a smoker</li>
<li>Have had any of the following: heart attack, coronary artery bypass graft surgery, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery</li>
<li>Have any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery</li>
<li>Have an aortic arch atheroma</li>
<li>Have an aortic aneurysm</li></ul>
For more information about this study, contact the study team at <a href= "mailto: megan.gonzalez@duke.edu">megan.gonzalez@duke.edu.</a>
<li>Are diagnosed with diabetes and have used insulin for at least 15 years</li>
<li>Have 2 of the following risk factors for atherosclerotic disease: hypertension (high blood pressure), dyslipidemia (LDL cholesterol > 130 mg/dl, HDL cholesterol < 40 mg/dl, triglycerides > 150 mg/dl, or using a cholesterol-lowering medicine), or are a smoker</li>
<li>Have had any of the following: heart attack, coronary artery bypass graft surgery, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery</li>
<li>Have any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery</li>
<li>Have an aortic arch atheroma</li>
<li>Have an aortic aneurysm</li></ul>
For more information about this study, contact the study team at <a href= "mailto: megan.gonzalez@duke.edu">megan.gonzalez@duke.edu.</a>
Age Range
30-49
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will get a random assignment (fair, equal chance) to take 1 of 3 different drug combinations. The 3 drug combinations to which you might be assigned to take are:<ul>
<li>Ticagrelor (Brilinta®) and aspirin</li>
<li>Rivaroxaban (Xarelto®) and aspirin</li>
<li>Copidogrel (Plavix®) and aspirin</li></ul>
After you get your study assignment, you will undergo Intensive Medical Therapy, which includes managing your blood pressure, cholesterol, and diabetes if applicable, along with programs to assist with smoking cessation and weight loss if needed.
<li>Ticagrelor (Brilinta®) and aspirin</li>
<li>Rivaroxaban (Xarelto®) and aspirin</li>
<li>Copidogrel (Plavix®) and aspirin</li></ul>
After you get your study assignment, you will undergo Intensive Medical Therapy, which includes managing your blood pressure, cholesterol, and diabetes if applicable, along with programs to assist with smoking cessation and weight loss if needed.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Principal Investigator
Shashank
Shekhar
Protocol Number
PRO00116160
NCT ID
NCT05047172
Phase
III
Enrollment Status
Pending Open to Enrollment