Stroke & Neurosurgery Clinical Trials

Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Principal Investigator: Sophia Sundararajan, MD, PhD

Study Purpose: This is a study being done to determine if treatment of obstructive sleep apnea with positive airway pressure after ischemic stroke or transient ischemic attack (TIA) reduced recurrent stroke, acute coronary syndrome, and death within six months of the initial stroke. It is also testing whether treatment of obstructive sleep apnea shortly after the ischemic stroke improves stroke recovery within three months. Automatically-adjusting positive airway pressure, aCPAP, will be tested against “usual care” for stroke patients with obstructive sleep apnea. Patients who meet criteria and consent to the study will be enrolled for six months.

Basic Inclusion Criteria:

• > 18 yrs 
• TIA with ABCD2 ≥4 or ischemic stroke within the prior 14 days
• independent ADLs prior to index stroke
• not currently using positive airway pressure or have not within one month of stroke

Study Coordinator:  Mary Andrews 216-844-2386

StATins Use in intRacereberal hemorrhage patieNts (SATURN)

Principal Investigator: Abhishek Ray, MD

Study Purpose: The purpose of this study is to find out if it is better to continue or discontinue statin drug on the risk of intracerebral hemorrhage (ICH) recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar ICH while taking a statin drug.

Basic Eligibility Criteria:  

• Spontaneous lobar ICH within 7 days prior to randomization confirmed by CT or MRI scan.
• Lobar ICH will be defined as ICH involving cortical or subcortical locations and situated ≥1 cm from the body of the ipsilateral lateral ventricle and not originating from any of the following deep structures (thalamus, putamen, globus pallidus, caudate, or internal capsule).
• Patient was taking a statin drug at the onset of the qualifying/index ICH
• Randomization must be carried out within 7 days of the onset of the qualifying ICH

Study Coordinator:  Mary Andrews 216-844-2386

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)

The purpose of this research study is to compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Drs. Martha Sajatovic and Carolyn Harmon Still are conducting a randomized controlled trial (RCT) that uses a psychoeducational approach to reduce the unacceptably high rates of stroke and stroke complications in African-American men. It is a person-centered, holistic intervention that takes advantage of existing strengths in African-American families and/or communities. TEAM uses peer educator dyads (PEDs) to provide support and model behaviors. The PED consists of an AA man peer educator with experience in managing his own stroke risk and his care partner. A care partner is a family member, friend or other individual who is important in the AA man’s stroke recovery.

Study Title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis

Principal Investigator:  Vikram Kashyap, MD (Vascular Surgery)

Basic Eligibility Criteria:

• ≥70% extracranial carotid stenosis by angio or ≥70% by duplex ultrasound defined by peak systolic velocity of at least 230 cm/s AND at least ONE of the following:
  • End diastolic velocity ≥ 100 cm/s, or
  • Internal carotid/common carotid artery PSV ratio ≥4.0 or
  • ≥70% stenosis  by CTA or
  • ≥70% stenosis by MRA
• No ipsilateral stroke or TIA ≥ 180 days of randomization
• No atrial fibrillation that requires anticoagulation
• mRS of 0 or 1 at time of informed consent

Study Coordinator: Carla Kinder at 216-844-2988

CATIVA Study

Principal Investigators: Dr Sepideh Amin-Hanjani and Dr. Amanda Opaskar

Study Purpose: The purpose of this research study is to determine if the investigational drugs, rivaroxaban or ticagrelor, or both are superior to the drug clopidogrel when it comes to lowering the rate of ischemic stroke, intracerebral hemorrhage, or vascular death 1 year after having a qualifying stroke.

Main Eligibility Criteria: Acute focal symptoms or signs of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting >24 hours that occurred within 30 days prior to randomization Index stroke in 1 above is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, middle cerebral artery (M1 or M2), vertebral artery (V4), basilar artery, posterior cerebral artery (P1), or anterior cerebral artery (A1)) documented by CTA, MRA, or catheter angiography. Modified Rankin Scale score of ≤ 4, at time of consent. Ability to swallow pills.

Study Coordinator: Mary Andrews 440-496-7905

ClinicalTrials.gov ID: NCT05047172