CAPTIVA (Stroke)

CAPTIVA (Stroke)

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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:
  • Are diagnosed with diabetes and have used insulin for at least 15 years
  • 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
  • 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
  • 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
  • Have an aortic arch atheroma
  • Have an aortic aneurysm
For more information about this study, contact the study team at megan.gonzalez@duke.edu.

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?

Description

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:
  • Ticagrelor (Brilinta®) and aspirin
  • Rivaroxaban (Xarelto®) and aspirin
  • Copidogrel (Plavix®) and aspirin
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
ClinicalTrials.gov