ENCHANTED-MT (ENCHANTED2) clinical trial holds its first national investigator meeting
The first National Investigator Meeting of ENCHANTED-MT (ENCHANTED2) study, co-organised by the George Institute for Global Health (China) and the First Affiliated Hospital of the Naval Medical University (Shanghai Changhai Hospital), was successfully held in Beijing recently.
The meeting was addressed by the study's co-principal investigators --- Professor Jianmin Liu from Shanghai Changhai Hospital and Professor Craig Anderson from the George Institute for Global Health (China). The experts at the meeting shared the progress of the project and the experiences of setting up the study and initial enrolment of patients.
In addition, as this study is jointly implemented by the ENCHANTED team of the George Institute for Global Health (China) and the DIRECT-MT team of Shanghai Changhai Hospital, the abbreviated name of the project, ENCHANTED-MT was released through the new logo launch event during the meeting.
ENCHANTED-MT builds upon the findings of the Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED) - which demonstrated the effects of low-dose thrombolysis treatment with rtPA, and of early intensive blood pressure lowering in patients with acute ischaemic stroke who were eligible for reperfusion therapy in the fist few hours after the onset of symptoms. ENCHANTED-MT aims to further determine the most appropriate level of blood pressure control in patients who receive mechanical thrombectomy for the most severe type of acute ischemic stroke, that caused by an occlusion of a large blood vessel to the brain.
This study is the first large clinical trial to address this important clinical and research question on patient-centred outcomes, to provide the highest-level of evidence for guideline and policy recommendations. The findings of a multicentre French study were published in early 2021 showing that intensive blood pressure lowering did not affect bleeding in the brain but it did not include a sufficiently large number of patients to reliably determine whether the treatment improve recovery after stroke.
According to the meeting, ENCHANTED-MT intends to be undertaken 80-100 hospitals in China, with 21 in 24 provinces/cities already participating. As of May 2021, the number of enrolled patients is 248, and enrolment is accelerating
Speaking at the meeting, Chao Baohua, Director of the Stroke Prevention and Treatment Engineering Committee of the National Health Commission(NHC), said that the project would "form a platform for Chinese people to understand the current situation and the treatment techniques of cerebrovascular disease domestically, while making professional contributions to the world at the same time."
Professor Liu Jianmin emphasised that ENCHANTED-MT is a major project directed by the NHC's Stroke Prevention and Treatment Engineering Committee, “traditional Chinese clinical trials have struggled to produce high quality studies; therefore it is particularly important for us to advance the project with high quality control by strictly following the GCP. We hope to publish the study eventually in well-known international journals, which in turn will improve clinical practice and outcome in China."
Professor Craig Anderson expressed his expectations via video: "Looking back on my 30 years’ medical career, I realised that the contributions of each team member and each patient are equally important to a well conducted clinical trial research. I am very much looking forward to everyone's continued efforts and further updates on the research."
Shortly after the first Investigators Meeting, ENCHANTED-MT held another communication meeting, inviting more than 80 investigators across China. At the meeting, training on blood pressure control and endpoint event assessment was reinforced, experiences in high-quality clinical research were shared, and specific requirements for project quality management were put forward. Experts from various fields, including statistics and clinical trials, as well as experienced lead investigators were invited to introduce a comprehensive overview of clinical research from different academic perspectives.