Clinical Trials

There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.

The purpose of this study is to determine if migraine patients engaged with the MICP will report improved migraine outcomes, increased satisfaction, and lower disability while reducing care-team workload and downstream utilization of face-to-face visits in primary care, neurology, and the emergency department.  

The purpose of this study is to test whether a short course of aspirin can change the markers of inflammation in patients who have a benign finding within five years of their last pregnancy, and possibly reduce their risk of future breast cancer.

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common, and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years, there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA, which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

This pilot, two-arm, randomized study will assess the feasibility of measuring the efficacy of aspirin, compared with observation, for reducing PGE2 and a subset of factors in paired biopsies of endometrium tissue from post-menopausal women. Eligible participants will undergo two endometrial biopsies (i.e. baseline, week-6, or sooner if chosen through shared decision making) separated by 6 weeks (+/- 7 days).

At both timepoints, blood and urine will also be collected to investigate mechanisms of tissue changes. As secondary aims, additional biomarker testing of paired biospecimens (urine, blood, and tissue) will be conducted to assess the correlation of results with treatment group, and clinicopathologic status of the endometrium (i.e. PMB and endometrial thickening). Also, correlations between collected urine, blood, and tissue measures will be explored.

Based on prior knowledge that age and body composition play a role in mechanisms related to endometrial status, sub-group analyses of the primary and secondary endpoints will be conducted. Additional sub-groups in race and ethnicity will be explored as the data allow, due to known differences in endometrial cancer mortality.

Finally, qualitative interviews will be utilized to investigate feasibility of future clinical trials in the community. 

The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

The main objective of this study is to compare a dual antithrombotic therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel,or ticagrelor 110mg dabigatran etexilate dual antithrombotic therapy (DE-DAT), and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a triple antithrombotic therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA ≤ 100mg q.d. (warfarin-TAT) in patients with atrial fibrillation that undergo a percutaneous coronary intervention with stenting (elective or due to an acute coronary syndrome).

The study aims to show non-inferiority of both doses of DE-DAT when compared to Warfarin-TAT in efficacy and safety. Efficacy will be determined by comparing a composite death and thrombotic event rate of death, myocardial infarction, stroke and systemic embolism. In addition, comparisons will be made of the rates of clinically relevant bleeding, assessed using the modified International Society of Thrombosis and Haemostasis (ISTH) major classification.

ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The primary endpoint is a composite of all-cause death, hospitalization for MI, or hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding with an associated blood product transfusion.

The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).