POINT- This study is sponsored by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS).
PI- Wade Smith, MD
The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke.
Patients who have had a TIA have a higher risk of developing a stroke. Recognizing and treating TIAs can reduce your risk of a stroke. Often, medication to prevent blood clots from forming is used to prevent a stroke in patients with blockage of one of the arteries in the brain. Low-dose aspirin has been shown to be effective in preventing strokes and heart attacks in patients who have had a TIA. Clopidogrel is another medication that is used to prevent strokes and heart attacks in patients at risk for these problems.
Clopidogrel is a type of medication called an antiplatelet drug, and it works by helping to keep platelets (small blood cells needed for normal blood clotting) in the blood from sticking together and forming harmful blood clots. This helps your blood flow more easily, and provides more protection against a future heart attack or stroke. Clopidogrel is approved for the prevention of a second stroke, and is taken once per day. Aspirin has also been shown to be effective in helping to prevent a second stroke or TIA, and is approved in doses ranging from 50 to 325 mg per day.
Several studies that tested the combination of clopidrogrel and aspirin have suggested that taking these two medications together may protect patients even more from major stroke and heart attack after a TIA or minor stroke, in comparison to taking aspirin alone, but these studies were small and the risk of bleeding was increased. The POINT trial has been designed to find out whether the combination of aspirin and clopidogrel reduces the risk of stroke, heart attacks and other complications compared to aspirin alone in patients like you. A single trial in China studying patients with stroke and TIA suggested that the combination of clopidogrel and aspirin was safe and effective. However, there are differences in the treatment of patients, the types of stroke, and the design of the trial, so it is not clear whether these results would apply to you.
Medtronic Stroke AF – This study is funded by Medtronic, Inc., (the “sponsor”) who pays the study site (UCSF) for the professional services and expenses related to this study, and provides the device being used in this study.
PI – Karl Meisel,MD
The purpose of this study is to compare how common Atrial Fibrillation ( AF) is in patients who have their heart activity continuously monitored using the Reveal LINQ ICM and in patients who are followed using standard of care medical treatment, when such patients recently had a stroke with a cause that is known.
The device being used in this trial is the Reveal LINQ ICM.
The U.S. Food and Drug Administration (FDA) has approved an Insertable Cardiac Monitor (ICM) called the Reveal LINQ™ ICM and accompanying MyCareLink® Home Monitor to monitor and assess heart rhythms. The Reveal LINQ ICM records heart activity and these recordings help doctors diagnose and decide how to treat abnormal heart rhythms. If you agree to be in this study, your doctor may insert a Reveal device under the skin of your chest to monitor your heart. The Reveal LINQ ICM is not usually inserted in patients with your type of stroke as part of standard treatment. However, the Reveal LINQ ICM is approved for use in patients like you, so its use is not investigational is this study.
The Reveal LINQ ICM, which is a small device about two inches long and approximately one quarter of an inch thick, will be placed under your skin. The Reveal LINQ ICM has two electrodes on its body that will continuously monitor your heart’s natural rhythms and activity and is powered by a battery that lasts for up to 3 years. The Reveal LINQ ICM can automatically detect and record abnormal heart rhythms.
EDGE NEWTON 2 This clinical research study is paid for by the sponsor, Edge Therapeutics.
PI- Nerissa Ko, MD
Nimodipine is a drug used to treat aSAH ( blood vessel in the brain burst and the blood entered a space called the subarachnoid space). It is given to patients to lower the possibility of DCI and vasospasm and to improve the chances of recovery. Nimodipine is usually given by mouth (orally) or through a feeding tube. Nimodipine can cause low blood pressure, which can be harmful. Nimodipine is approved by the US Food and Drug Administration (US FDA) for the treatment of aSAH.
The investigational drug EG-1962 is a new form of nimodipine that is given through a ventricular catheter directly into the brain. The goal is to deliver the medication once directly into the brain to reduce the side effect of low blood pressure and possibly to increase the chance of a better recovery. The purpose of this study is to understand if giving nimodipine given through a brain catheter already in place is safe and effective compared to giving the medication orally or through a feeding tube.
RESPECT ESUS – This study is funded by Boehringer Ingelheim Pharmaceuticals, Inc., (the “sponsor”) who pays the study site (UCSF) for the professional services and expenses related to this study, and provides the investigational drug being used in this study.
PI – Karl Meisel, MD
The purpose of this study is to test the safety and effectiveness of the medication called dabigatran etexilate taken twice daily compared to aspirin (acetylsalicylic acid) taken once daily in reducing the risk of stroke in patients with ESUS.
Patients who have had a stroke due to a blood clot, including those with ESUS, have a higher risk of developing another stroke. Currently, it is unclear how best to prevent another stroke in subjects with ESUS. These patients are often given one or more antiplatelet drugs which help keep platelets (blood cells that normally help blood clot) from clumping and creating harmful clots. Common antiplatelet drugs are aspirin, clopidogrel, and ticlopidine.
Another type of medication commonly used to prevent stroke in at-risk patients are blood thinning medications known as anticoagulants that work by preventing blood clots from forming or growing by decreasing the blood’s ability to clot. Dabigatran etexilate is one such type of anticoagulant drug that may provide more protection against a future stroke or heart attack.
The use of dabigatran etexilate and aspirin are considered investigational drugs for the purpose of this study. An investigational drug is one that is not approved for use in this particular problem in humans by the United States Food and Drug Administration (FDA). While aspirin 81 or 325 mg once daily is used in medical practice, this study will be providing aspirin 100 mg (Acetylsalicylsäure 100 mg HEXAL®), an aspirin product that is not commercially available in the United States.