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Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05047172
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : January 13, 2023
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Medical University of South Carolina
Janssen Scientific Affairs, LLC
AstraZeneca
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Arteriosclerosis Stroke Drug: Ticagrelor + Aspirin Drug: Rivaroxaban + Aspirin Drug: Clopidogrel + Aspirin Other: Risk Factor Management Phase 3

Detailed Description:
The proposed study is relevant to public health because narrowing of brain arteries is one of the most common causes of stroke worldwide. Compelling evidence suggests novel antithrombotic medications could reduce the rate of stroke in patients with narrowed brain arteries. The proposed study will directly compare novel antithrombotic medications to standard care antiplatelet medications for preventing stroke and death from vascular causes in patients with narrowed brain arteries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 1:1:1 treatment allocation
Primary Purpose: Prevention
Official Title: Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : April 30, 2027
Estimated Study Completion Date : April 30, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Arm: Ticagrelor and Aspirin
Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Drug: Ticagrelor + Aspirin
ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Other Name: Brilinta

Other: Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.

Active Comparator: Standard of Care Arm: Clopidogrel and Aspirin
Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)
Drug: Clopidogrel + Aspirin
clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
Other Name: Plavix

Other: Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.

Experimental: Experimental Arm: Rivaroxaban and Aspirin
Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Drug: Rivaroxaban + Aspirin
low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Other Name: Xarelto

Other: Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.




Primary Outcome Measures :
  1. Number of participants with parenchymal brain hemorrhage (ICH) or major non-ICH hemorrhage [ Time Frame: Up to 12 months ]

    Major non-ICH hemorrhage is defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria consisting of:

    • Fatal bleeding, and/or
    • Symptomatic bleeding in a critical area or organ, such as subarachnoid, intraventricular, subdural, epidural, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
    • Symptomatic bleeding causing a fall in hemoglobin level of 1.24 mmol/L (20g/L or greater) or more, or leading to transfusion of two units or more of whole blood or red cells

  2. Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death [ Time Frame: Up to 12 months ]
    The definition of ischemic stroke is the American Heart Association definition that also includes signs or symptoms lasting < 24 hours associated with an acute infarct on brain imaging.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms or signs of any duration associated with an infarct on brain imaging that occurred within 30 days prior to randomization
  • Index infarct is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) documented by CTA, MRA, or catheter angiography
  • Modified Rankin score of ≤ 4
  • Ability to swallow pills
  • Age 30-80 years, inclusive, at time of consent
  • Subjects 30-49 years of age are required to meet at least ONE of the following additional criteria below to qualify for the study:

    1. diabetes treated with insulin for at least 15 years
    2. at least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL < 40 mg/dl or fasting triglycerides > 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; any of the following vascular events occurring in a parent or sibling who was < 55 years of age for men or < 65 years of age for women at the time of the event: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery for atherosclerotic disease
    3. personal history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
    4. 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 that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
    5. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
    6. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic
  • Negative pregnancy test in a female who has had any menses in the last 18 months and has not had surgery that would make her unable to become pregnant
  • Subject is willing and able to return for all follow-up visits required by the protocol
  • Subject is available by phone
  • Subject understands the purpose and requirements of the study and can make him/herself understood
  • Subject has provided informed consent (use of a LAR is not permitted)

Exclusion Criteria:

  • Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, including mechanical thrombectomy for the qualifying stroke, or plan to perform one of these procedures
  • Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to the symptomatic intracranial stenosis
  • Intracranial tumor (except meningioma) or any intracranial vascular malformation
  • Thrombolytic therapy within 24 hours prior to randomization
  • Progressive neurological signs within 24 hours prior to randomization
  • History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
  • Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus
  • Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, left atrial spontaneous echo contrast
  • Known allergy or contraindication to aspirin, rivaroxaban, clopidogrel, or ticagrelor.
  • Active peptic ulcer disease, major systemic hemorrhage within 30 days prior to randomization, active bleed or bleeding diathesis, platelets < 100,000, hematocrit < 30, INR > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (AST or ALT > 3 x normal, cirrhosis), or CrCl < 15 mL/min or on dialysis
  • Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days prior to randomization or planned in the next 90 days after randomization
  • Any condition other than intracranial arterial stenosis that requires the subject to take any antithrombotic medication other than aspirin (NOTE: exceptions allowed for subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis while hospitalized)
  • Severe neurological deficit that renders the subject incapable of living independently
  • Dementia or psychiatric problem that prevents the subject from following an outpatient program reliably
  • Co-morbid conditions that may limit survival to less than 12 months
  • Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study, or currently breastfeeding
  • Current or anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or CYP3A4 substrates that cannot be stopped for the course of this study
  • Enrollment in another study that would conflict with the current study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05047172


Contacts
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Contact: Stephanie McLaren, BSN, RN 888-351-7776 CAPTIVA-Study@ufl.edu
Contact: Renee Boyette, BSN, RN 888-351-7776 CAPTIVA-Study@ufl.edu

Locations
Show Show 51 study locations
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Medical University of South Carolina
Janssen Scientific Affairs, LLC
AstraZeneca
Investigators
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Principal Investigator: Brian L. Hoh, MD, MBA University of Florida
Principal Investigator: Marc I. Chimowitz, MBChB Medical University of South Carolina
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT05047172    
Other Study ID Numbers: CED000000522
AWD10099 ( Other Identifier: UFIRST )
U01NS117450 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Rivaroxaban
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists