2023-08-11 17:45:08
A clinical trial called APRIL has evaluated the effect of an innovative neuroprotective drug called ApTOLL in combination with endovascular treatment in patients with acute ischemic stroke.
The study is the work of a team led by Macarena Hernández-Jiménez from aptaTargets in Madrid (Spain), and which also includes specialists from the Bellvitge Hospital and the Bellvitge Biomedical Research Institute (IDIBELL), located in Hospitalet de Llobregat and which is one of the CERCA institutions of the Generalitat of Catalonia.
The study has shown that administration of ApTOLL within 6 hours of stroke, together with endovascular treatment, is safe and well tolerated.
In addition, patients receiving ApTOLL showed a significant reduction in mortality (from 18% to 5%) and improved function at 90 days compared to patients receiving placebo.
Dr. Pere Cardona, director of the Stroke Unit at Bellvitge University Hospital (HUB) and principal investigator of IDIBELL’s Neurological and Neurogenetic Diseases group, highlighted the importance of these results: “ApTOLL is the first neuroprotective drug that has shown great efficacy and safety in the acute phase of severe stroke. This makes it a promising candidate for future studies in hospital and prehospital settings.”
Dr. Peter Cardona (Photo: IDIBELL / Bellvitge University Hospital)
The APRIL study was carried out in 14 stroke reference centers in Spain and France and included 151 patients who were randomized to receive ApTOLL or a placebo before thrombectomy, the main endpoint being safety determined by death, symptomatic intracranial hemorrhage; and malignant and recurrent cerebrovascular accidents. Infarct volume and severity of symptoms at 72 hours and disability at 90 days were also assessed.
Stroke is a serious disease that will affect 1 in 4 adults over the age of 25 throughout their lives, with acute ischemic stroke being the most common form. Despite reperfusion treatments, many patients continue to develop significant disabilities. Therefore, ApTOLL emerges as a promising hope as a neuroprotective drug to improve stroke outcomes in combination with other treatments. In addition, it is important to note that ApTOLL already has priority drug designation from the European Medicines Agency (EMA), recognizing its potential importance in the medical field.
The study is titled “Safety and Efficacy of ApTOLL in Patients With Ischemic Stroke Undergoing Endovascular Treatment: A Phase 1/2 Randomized Clinical Trial”. And it has been published in the academic journal JAMA Neurology. (Source: IDIBELL)
#neuroprotective #drug #ischemic #stroke