Intensive Medical Therapy for Carotid Artery Stenosis

(SCORE Trial)

This trial tests a new treatment approach called Intensive Medical Therapy (IMT) for preventing strokes in individuals with symptomatic carotid stenosis, which is the narrowing of neck arteries supplying blood to the brain. The goal is to determine if IMT, which includes medications like statins and antiplatelets, along with blood pressure control and lifestyle changes, can maintain a stroke rate under 5% within one year for those with lower risk features. Suitable candidates have experienced a stroke or a temporary stroke-like event (TIA) on the same side as their carotid artery narrowing (50-99%) and meet criteria suggesting lower stroke risk, such as having had a recent stroke more than a week ago or being female. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

The trial information does not specify if you need to stop taking your current medications. However, it mentions that the study involves Intensive Medical Therapy, which might include changes to your medication regimen. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that Intensive Medical Therapy (IMT) is generally well-tolerated. This therapy often includes a mix of blood thinners, cholesterol-lowering drugs, blood pressure control, and lifestyle changes, all common in medical care.

While specific safety data for IMT is not available, these medications are widely used for heart and artery conditions and have been approved for other uses, indicating safety when monitored by a doctor. Some individuals might experience side effects, such as muscle pain from cholesterol drugs or an increased risk of bleeding from blood thinners. However, doctors typically manage these side effects by adjusting doses or changing medications.

Researchers are excited about Intensive Medical Therapy for symptomatic carotid stenosis because it takes a comprehensive approach to treatment, potentially offering more effective outcomes than traditional methods. Unlike the typical approach that might focus on a single aspect like surgery, this therapy combines several elements: dual antiplatelet therapy, high-potency statins, blood pressure control, and lifestyle modifications. This multifaceted strategy aims to reduce the risk of stroke by addressing multiple risk factors simultaneously, offering a promising alternative to conventional treatments.

Research has shown that Intensive Medical Therapy (IMT), which participants in this trial will receive, can lower the risk of stroke in people with carotid artery narrowing. Previous studies demonstrated that carotid endarterectomy (CEA), a type of surgery, effectively prevents strokes, but IMT offers a non-surgical alternative. IMT includes treatments such as taking two types of blood-thinning medications, using strong cholesterol-lowering drugs, controlling blood pressure, and making lifestyle changes. These treatments reduce stroke risk by managing factors like cholesterol and blood pressure. Some studies found that the risk of stroke over five years with medical therapy alone was about 7.5%, indicating room for improvement with modern IMT methods. This approach aims to reduce the stroke rate to less than 5% in one year for patients with low-risk carotid narrowing.²³⁶⁷⁸