Stroke Clinical Trials
The stroke program at UW Health, University of Wisconsin Hospital and Clinics in Madison, Wisconsin conducts regular clinical trials for patients who are interested and qualified for enrollment.
The list below discusses parameters of current clinical trials offered through UW Health's stroke program.
RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment)
Topic: Patent foramen ovale
Purpose of study: This is a randomized, active control, blinded, adjudicated outcome clinical trial to investigate whether percutaneous PFO closure is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Inclusion Criteria
Patients age 18-60 with patent foramen ovale who have had a cryptogenic stroke within the last 270 days.
More Information
Patients are randomly assigned to best medical therapy or PFO closure with the AMPLATZER PFO Occluder. Best medical therapy treatment options include aspirin alone, Coumadin alone, clopidogrel alone or aspirin combined with dipyridamole.
Study contact: Call (608) 263-9602 or amharris@clinicaltrials.wisc.edu.
RACER (Researching AXIUM Coiling Experience and Recanalization)
Topic: Cerebral aneurysm coiling
Purpose of study: This trial is a non-randomized, open label, single group assignment and will collect data to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. The device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007.
Inclusion Criteria
- Patient or patient's legally authorized representative has signed and dated an informed consent form
- Must be at least 18 years of age
- Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical/interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable
- Patient is willing to conduct follow-up visits
Exclusion Criteria
- Aneurysm was previously treated
- Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the study procedures
- Patient is participating in another clinical research study
- Patient has a medical, social or psychological condition, which precludes the patient from receiving study required treatment, evaluation, procedures and follow-up
- Female patient is pregnant or breast-feeding
More Information
A synopsis is available at http://clinicaltrials.gov/ct2/show/NCT00703794?term=axium&rank=1.
Study contact: (608) 262-7269
IRIS (Insulin Resistance Intervention after Stroke Trial)
Topic: Medical prevention of recurrent stroke
Purpose of study: This is a randomized, double-blinded, placebo-controlled trial of pioglitazone (Actos) for the prevention of recurrent stroke and other vascular events. The trial includes subjects who are not diabetic but have insulin resistance as determined by an investigational blood test.
Inclusion Criteria
Eligible patients:
- Will not be taking diabetic medication
- Had a recent non-embolic ischemic stroke or TIA within 180 days
- Are insulin-resistant
Exclusion Criteria
- Stroke/TIA caused by trauma or carotid dissection
- Life-limiting cancer
- Congestive heart failure
- Severe liver disease
- Severe neurologic or psychiatric disease
- Use of oral contraceptives or oral steroids
- Pregnancy
- Life expectancy of less than five years
- Glycated hemoglobin level greater than seven
More Information
Patients will be randomized to receive either 15 mg tablets of pioglitazone or placebo. The medication will be increased each month to a final dose of three pills daily. Thereafter, participants will receive tablets containing placebo or 45 mg pioglitazone once daily. After dose escalation, participants will be followed with scheduled telephone calls and annual in-person visits. Blood is drawn at four months and annually for safety and efficacy measures.
A synopsis is available at http://www.strokecenter.org/trials/trialDetail.aspx?tid=596&search_string=iris
Study contact: Call (608) 287-2863 or e-mail dmd@clinicaltrials.wisc.edu.
MAPS (Matrix and Platinum Science Trial)
Topic: Intracranial aneurysms
Purpose of study: To investigate Matrix 2 and GDC, detachable coils for the treatment of intracranial saccular aneurysms (a sac-like outpouching in a cerebral blood vessel).
Inclusion Criteria
- Patient is between 18 and 80 years of age
- Patient has an untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils
- Both GDC® Coils and Matrix 2® Coils
- Target aneurysm can be coiled at index procedure (NO staged coiling procedures)
- Patient (or patient's legally authorized representative) has provided written informed consent
- Patient is willing and able to comply with protocol follow-up requirements
Exclusion Criteria
- Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting)
- Target aneurysm has been previously treated by surgery or endovascular therapy
- Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm
- Patient presents with Modified Rankin Score 4 or 5 at baseline
- Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor
- Patient has known hypersensitivity to Polyglycolic Polylactic Acid (PGLA), platinum, nickel, stainless steel or structurally related compounds found in Matrix 2® Coils and/or GDC® Coils
- Planned use of adjunctive therapy stents except Neuroform is not allowed
- Patients with multiple aneurysms
Contact: Call Julie Grinde at (608) 262-2939 or e-mail the PI at baagaard-kientiz@uwhealth.org.
Preventing Stroke and Heart Attack Among Patients with Recent Ischemic Stroke or TIA
Purpose of study: To investigate whether the use of pioglitazone (a drug used to treat insulin resistance) reduces the risk of future strokes and heart attacks in patients who have had a recent stroke or transient ischemic attack (TIA) and also have a condition called insulin resistance.
Inclusion Criteria
- Greater than 40 years of age
- Have had an ischemic stroke or TIA within the last six months (must be at least 14 days after stroke to enroll)
- Diagnosis of insulin resistance (defined as having a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity)
Exclusion Criteria
- Not able to abulate with assistance
- Had stroke related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation
- Diabetes mellitus
- Neurologic/psychiatric disorders
- Pregnancy or desire to become pregnant
- Oral contraceptive use
- Ongoing use of oral corticosteroids
- History of heart failure
- Active liver disease
- History of bladder cancer
More Information
- Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effect. Insulin resistance can lead to diabetes and is thought to cause blood vessel diseases, including stroke and heart attack, in patients with and without diabetes.
- Participating stroke patients will be assigned to receive pioglitazone, a medication which reduces insulin resistance, or placebo (an inactive look-alike pill). Patients will stay on their assigned treatment for about four years. At the end of the study, investigators will compare the experience of patients on pioglitazone and placebo to see which group had fewer recurrent strokes and heart attacks.
Study contact phone: (608) 263-9602
SWISS (Siblings With Ischemic Stroke Study)
Topic: Stroke genetics
Purpose of study: SWISS is an NIH-funded study of people who have had an ischemic stroke and have a sister or brother who has also had an ischemic stroke. An ischemic stroke is a stroke caused by a blockage of the blood flow through the blood vessels. About 85 percent of all strokes are ischemic strokes.
About the Study
- If you agree to participate in the study, you will be asked to send study letters to your brothers and sisters who have also had an ischemic stroke inviting them to also take part in the study.
- Once investigators verify that you and your siblings qualify for the SWISS study, a home health care agency representative will make an appointment with you to come to your home and draw blood from you. You do not have to make a special trip to the medical center for a blood draw. Your part in the study is over once your blood is drawn.
- Your DNA will be sent out to the SWISS study investigators to analyze for regions in the human genome that seem to be linked with stroke. We hope to understand what caused your stroke and the strokes of many other people, including your family members.
More Information
A synopsis is available at http://www.strokecenter.org/trials/TrialDetail.aspx?tid=236.
Study contact: (608) 263-4505 or e-mail at pkw@clinicaltrials.wisc.edu.
Carotid Endarterectomy
Purpose of study: The purpose of this study is to look at the differences in the plaque (the hard formation on the artery walls formed by fat and cholesterol deposits) in people with symptomatic and asymptomatic carotid stenosis (narrowing of the carotid arteries). The plaque buildup in a person who has had a stroke or transient ischemic attack (TIA) is called symptomatic. A person who has no symptoms or has not had a stroke is called asymptomatic. Not all people who have plaque will have a stroke.
About the Study
- This study uses various techniques to look at the differences in people who have carotid stenosis. Some have had stroke and some have not. If such differences can be found, it might allow doctors to identify people who have an increased risk of having these types of strokes.
- A research ultrasound of the neck/carotid artery (prior to surgery), a research trans-cranial doppler and a paper and pencil test of how you are thinking will be done prior to your surgery and at 3 months after surgery.
Study contact: (608) 263-4505 or e-mail at pkw@clinicaltrials.wisc.edu.
