Intensive Medical Therapy for Carotid Artery Stenosis
(SCORE Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Will I have to stop taking my current medications?
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.
Is there any evidence suggesting that Intensive Medical Therapy is likely to be safe for humans?
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.
Prospective trial participants should discuss any concerns with their doctor, who can help them understand the risks and benefits based on personal health needs.12345Why are researchers excited about this trial?
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.
What evidence suggests that Intensive Medical Therapy might be an effective treatment for symptomatic carotid stenosis?
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
Who Is on the Research Team?
Seemant Chaturvedi, MD
Principal Investigator
School of Medicine, University of Maryland
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a survey/questionnaire at baseline
Intensive Medical Therapy
Participants receive intensive medical therapy, including dual antiplatelet therapy, high potency statins, BP control, and lifestyle modification
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveys/questionnaires at 6 and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Intensive Medical Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor