Venous Sinus Thrombosis due to Vaccine-Induced Thrombotic Thrombocytopenia (VITT): A Case Report

Patient, 19-year-old male, presented with fever, abdominal pain, headache, and vomiting presented after vaccination with ChAdOx1 CoV-19 (AstraZeneca, University of Oxford, and Serum Institute of India, and adenoviral-based vaccine) with alteration in sensorium and thrombocytopenia. He was diagnosed to have extensive venous sinus thrombosis with mass effect, midline shift, and underwent decompressive hemicraniotomy. He had a good outcome. </jats:p

INSTRuCT

Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to be initiated. SPRINT trial randomized first patient on April 28, 2018; recruited 3048 patients with an average of 128.5 per month so far. The first follow-up was completed on May 27, 2019. RESTORE trial randomized first patient on May 22, 2019; recruited 49 patients with an average of 3.7 per month so far. The first follow-up was completed on August 30, 2019. Conclusions: In next 5 years, INSTRuCT will be able to complete high-quality large scale stroke trials which are relevant globally. REGISTRATION: URL: http://www.ctri.nic.in/ ; Unique Identifier: CTRI/2017/05/008507. </jats:sec

Statistical Analysis Plan for the Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA): A Randomized Controlled Trial

Background: Recurrent stroke is one of the major causes of death in stroke patients. Introducing stroke prevention education package to improve the lifestyle behavioral factors could reduce the vascular events. The Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package (SPRINT) study in India aims to assess the role of a stroke prevention education package to reduce recurrent strokes, myocardial infarction, and death in patients with stroke. The objective is to formulate the detailed statistical analysis plan for the SPRINT India prior to trial unblinding. Methods: The plan was developed by trial statisticians with the help of principal investigator and management team of the SPRINT study. The chosen primary and secondary outcome measures and knowledge of critical baseline data were used to construct the statistical analysis plan. All collected data will be thoroughly reviewed. Patient baseline characteristics will be summarized with relevant descriptive statistics. The findings are planned and explained for the most appropriate statistical comparison between the groups. Results: The final statistical analysis plan corresponds to established criteria and will allow for transparent and efficient reporting. Conclusions: The SPRINT trial statistical analysis plan is developed in order to avoid analysis bias arising from prior knowledge of findings and to explicitly summarize prespecified analyses. </jats:sec

STENOSIS: Long-term single versus dual antiplatelet therapy in patients with ischaemic stroke due to intracranial atherosclerotic disease – a randomised trial

Rationale Intracranial atherosclerotic disease (ICAD) is a pathological process that causes progressive stenosis and cerebral hypoperfusion, leading to stroke occurrence and recurrence around the world. The exact duration of dual antiplatelet therapy (DAPT) for ICAD is unclear in view of long-term risk of bleeding complications.Aim The current study aims to study the efficacy and safety of long-term DAPT (up to 12 months) in patients with ICAD.Sample size Using 80% power and an alpha error of 5 %, presuming a 10%–15% drop-out rate, a total of 2200 patients will be recruited for the study.Methodology This is a prospective, randomised, double-blind, placebo controlled trial.Study outcomes The primary outcomes include recurrent ischaemic stroke (IS) or transient ischaemic attack and any intracranial haemorrhage (ICH), major or minor systemic bleeding at the end of 12 months. Secondary outcomes include composite of any stroke, myocardial infarction or death at the end of 12 months. The safety outcomes include any ICH, major or minor bleeding as defined using GUSTO (Global Use of Streptokinase and tPA for occluded Coronary Arteries) classification at the end of 12 months and 1 month after completion of the drug treatment phase.Discussion The study will provide level I evidence on the duration of DAPT among patients with IS due to ICAD of more than or equal to 50%