Latest news with #PLATO
The Hindu
16-07-2025
- Science
- The Hindu
No need for more technocrats, IIT Kharagpur to focus on human-centric R&D, says Director
On the 71st convocation of the Indian Institute of Technology on Tuesday (July 15, 2025), Kharagpur (IIT-KGP) director Dr. Suman Chakraborty said 'the world does not need more technocrats', highlighting the institute's renewed focus on human-centric, multidisciplinary technology research. 'Let me be clear: the world does not need more technocrats. It needs humans who can think and feel — who can use algorithms, but are not ruled by them. The future belongs to those who can combine emotional intelligence with technical intelligence,' the director said. In an exclusive interaction with select media, Mr. Chakraborty elaborated that earlier, technocrats relied on extensive research and skill-learning, whereas in the current day scenario, AI systems like ChatGPT can generate answers to most science and tech questions. 'Unfortunately, it will take a whole lot of time to create a four-year undergraduate programme where answers will not be generable by ChatGPT. So, when these things are already there, students have to elevate themselves where they can innovate, interpret between lines, converge between domains, and come up with solutions that are both technologically advanced as well as human-centric,' the director said. He added that IIT KGP is looking to equip future students with the knowledge of using AI more ethically. Focus on convergence Mr. Chakraborty also highlighted how the research on AI, deeptech, cloud computing, etc., at IIT KGP is advancing in converging domains, with a mix of traditional and non-traditional subjects like AI in diagnostics, medicine, law, humanities, etc. 'In terms of research on AI, we are also thinking of exploring certain domains where the research will be led by non-AI domain experts… Usually, the engineering and science departments kick off science and tech projects, taking humanities and social sciences as complementary aspects in some cases. In that way, we are concerned with how AI can be more empathetically used to bridge the gap between AI and humans,' he said. Mr. Chakraborty also said that IIT KGP is pushing boundaries with research across cybersecurity, AI, cloud computing, and disease modelling. He added that the AI models designed by the institute are being used for disaster response and precision agriculture. 'Our AI department, now a full-fledged academic unit, offers BTech., MTech., and interdisciplinary dual degree programs. It has become a national leader in responsible and explainable AI with real-world applications in healthcare, climate, and linguistics, and with emphasis on human-centric AI… we are therefore not just building machines, we are building meaning,' he added. The Director also unveiled PLATO, an AI-powered coding tutor that offers real-time, personalised guidance to students learning computer programming. Better amenities at IIT KGP The director said that the institute is working on its 'shortcomings' to make itself a more preferred choice for nationwide talent. 'We are good at classroom teaching, but beyond that, we are working on improving infrastructure, improving quality of life, and making campus life more vibrant. We should connect everything. As part of our Platinum Jubilee, we are also building a special amenities centre, an all-in-one unit that can help students have an enjoyable lifestyle while facilitating all-round growth,' Mr. Chakraborty said. More women in STEM Mr. Chakraborty also touched upon the global gender disparity in science, technology, medicine and engineering, 'Women are not just contributors — they are disruptors, creators, and changemakers — and at IIT KGP, we thrive not merely to preach this spirit but portray the same in practice,' he added. Notably, gender ratios in several branches of the IIT remain skewed despite girl students excelling in all-India examinations. On Tuesday, less than half of the graduating students being awarded prestigious medals at IIT KGP's convocation ceremony were women. 71st convocation This year, IIT KGP awarded a total of 3,731 degrees across various disciplines, including 277 PhD, 18 MS, 956 50 MCP, 142 MBA, 23 EMBA, 58 PGDBA, 5 MMST, 28 MHRM, 18 47 LLM, 31 LLB, 786 Dual Degree, 614 (Hons), 46 (Hons), 151 Four-Year B.S, 260 Five-Year 214 Two-Year 3 3 Three-Year and 1 Certificate of Excellence in Research (CER). Awards such as the President's Gold Medal, Prime Minister's Gold Medal, and others were conferred upon graduating students and scholars. Dr. S. Somanath, former chairperson of the Indian Space Research Organisation (ISRO), was the chief guest.
Medscape
20-06-2025
- Health
- Medscape
BMJ Investigation Increases Concerns About Ticagrelor Trials
An investigation by The BMJ is raising fresh concerns about the clinical studies that supported the approval of the antiplatelet drug ticagrelor (Brilinta, AstraZeneca), almost 15 years after the medication was first approved and as generic versions are set to hit the market. Peter Doshi, PhD, a senior editor at The BMJ , previously reported inconsistencies and omissions in data reporting from the 2009 PLATO study, published in The New England Journal of Medicine , which showed ticagrelor was superior to clopidogrel in treating acute coronary syndrome. Now a follow-up investigation of two supporting studies published in Circulation , ONSET/OFFSET and RESPOND, has revealed primary endpoints were reported inaccurately, data were missing from the submission to the US Food and Drug Administration (FDA), and study centers may not have received adequate training. Doshi said the results of his investigations call into question the drug's approval and suggested that it should be revisited. 'The FDA's approval in 2011 went against the evidence according to its reviewers, and now, my investigations into PLATO, ONSET/OFFSET, and RESPOND, suggest that even the data presented to the FDA and reported in The New England Journal of Medicine and Circulation , is not trustworthy,' he told Medscape Medical News. The investigation identified several problems with data integrity in the two trials. The original primary endpoint results for RESPOND, which aimed to test whether ticagrelor could convert nonresponders to clopidogrel into responders, were statistically nonsignificant ( P = .157) but were subsequently reported in Circulation as significant ( P = .005) because of an undeclared change in its primary endpoint definition. For ONSET/OFFSET, which reported ticagrelor provided faster and greater inhibition of platelets than clopidogrel, the investigators now claim several patients were excluded from the analysis. However, those who remained were identified as the 'intention-to-treat' population, implying all patients were included. Implausible data points were also included in the analysis of the primary endpoint but were first transformed through an unpublished data analysis, Doshi claimed. Doshi also gained access to readouts from some of the platelet function test machines used in the trial. He found more than 60 of 282 readings were not present in the datasets submitted to the FDA, and the levels of platelet activity in those readings were significantly higher than those reported in Circulation . Victor Serebruany, MD, from Johns Hopkins University in Baltimore, and one of the more high-profile critics of ticagrelor, told The BMJ the missing readings show 'there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor, making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.' The investigation also revealed oddities around the authorship of the publications. One active trial investigator was never identified as a study author, while one author told The BMJ he was not involved in the trial. The BMJ states that AstraZeneca, the journal Circulation , and many of the original investigators either declined to comment on the new claims or were unreachable. Ticagrelor has been under fire since the beginning. The drug failed in its first bid for FDA approval and was the subject of an investigation by the US Department of Justice in 2013 at the urging of Serebruany. That investigation was closed in 2014 with no further action. A review of several major trials of ticagrelor by Eric Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor, Michigan, and a co-author of the US guidelines that recommend ticagrelor, concluded 'the clinical conventional wisdom and clinical trial guideline support for…ticagrelor compared with clopidogrel may be overemphasized.' Bates is now calling for a review of ticagrelor's recommendation in guidelines, according to the earlier The BMJ report.
Medscape
12-05-2025
- Health
- Medscape
Is a Year of DAPT Magical Thinking?
Christopher Labos, MDCM, MSc It's hard to accept that babies born in the year 2000 now have kids of their own. It's even harder to accept that there never was much evidence for 12 months of dual antiplatelet therapy (DAPT) after coronary stenting. In a recent commentary, lead author Marco Valgimigli, MD, PhD, likened the routine use of 1 year of DAPT to a myth that has become entrenched in our collective culture. Though recent trials suggest shorter durations are feasible and possibly better, untangling truth from myth is proving to be a Gordian knot. Enter the DAPT Era The era of DAPT began with the publication of the CURE study in 2001. Patients with non-ST elevation myocardial infarction were randomized to aspirin plus clopidogrel or aspirin plus placebo. Despite the increased bleeding seen with the addition of clopidogrel, the trial's positive primary outcome prompted many, myself included, to start putting patients on both drugs. As more potent anti-platelets such as prasugrel and ticagrelor came to market, on the basis of TRITON-TIMI 38 and PLATO , respectively, the idea of yearlong double therapy was reinforced. But in TRITON-TIMI 38, median treatment duration was 14.5 months and in PLATO it was just over 9 months. Neither study provided 12 months of DAPT nor tested a specific duration of therapy. The subject grew more complicated as the field evolved. Bare metal stents improved and then gave way to drug eluting stents which in turn evolved to newer iterations with better scaffolds, polymers, and anti-proliferative agents. In the early 2000's, the risk of stent thrombosis with the first generation of drug-eluting stents prompted a science advisory stressing the importance of 12 months of DAPT. Even though the risk of late stent thrombosis is much reduced with the newer generation of drug eluting stents, a confluence of factors made 12 months of DAPT the standard of care. But a blanket 1-year recommendation ignores the past quarter century's dizzying evolution in stents, angiography techniques, and background medical therapy. We can justifiably question if studies from 20 or even 10 years ago are still relevant and if the particular risk and medication profile of the patient sitting in front of you has been adequately represented in the clinical trials. Balancing Ischemic Benefit and Bleeding Risk Multiple trials have tested alternatives to 12 months of DAPT. The DAPT trial tested 12 months vs 30 months of DAPT and found fewer stent thromboses and cardiovascular events with longer treatment but at the cost of more bleeding. This trade-off has been replicated many times and a meta-analysis of five trials of longer term DAPT showed that extending treatment beyond 12 months reduced cardiovascular events but resulted in more bleeds. This balance between cardiovascular benefit and bleeding risk prompted the question of shorter durations than 12 months. A summary of this body of evidence suggests that 3-6 months had no major impact on either stent thrombosis and paradoxically bleeding risk compared with 12 months. While those de-escalation trials usually left patients on aspirin alone, an alternative would be to stop the aspirin and leave them on a P2Y12 inhibitor. Multiple trials have tested a variety of permutations. The SMART-CHOICE trial de-escalated to clopidogrel in most patients after 3 months of DAPT, STOPDAPT-2 de-escalated to clopidogrel after 1 month of DAPT, while TWILIGHT tested ticagrelor monotherapy after 3 months of DAPT in a high-risk population. Keeping this heterogeneity in mind, meta-analyzing these trials suggests that ticagrelor alone after 1-3 months of DAPT reduces the bleeding risk without increasing cardiovascular events. Whether we can say the same for prasugrel is less clear. The STOPDAPT-3 trial tried an 'aspirin free' strategy with prasugrel monotherapy at 3.75 mg daily rather than the standard 10 mg dose. This strategy did not improve bleeding rates or worsen the primary endpoint, suggesting that prasugrel monotherapy may be feasible. But the atypical dosing and general unpopularity of prasugrel does make it a challenging trial to put into practice. But Wait There's More De-escalation Trials At the recent American College of Cardiology scientific sessions in Chicago, there were even more data to add to the mix. The HOST-BR trial tested two different regimens based on the patient's bleeding risk. High risk patients were randomized to 1 vs 3 months of DAPT and low risk patients were randomized to 3 vs 12 months, with clopidogrel being the most common second anti-platelet. In high bleeding risk patients, limiting DAPT to 1 month increased major adverse cardiac and cerebral events (MAACE) at 1 year by 4.0% on the absolute scale with a non-significant trend towards less bleeding. By contrast, in the low-bleeding-risk patients, limiting DAPT to 3 months instead of 1 year had no major effect on MAACE but reduced bleeding by 9.5% on the absolute scale. In both the high and low risk patients, 3 months of DAPT seemed to be the sweet spot. SMART-CHOICE 3 took a different tack and evaluated patients that had already completed their 'standard' duration DAPT (12 months post myocardial infarction and 6 months overwise) and randomized them to monotherapy with aspirin vs clopidogrel. At 3 years, clopidogrel reduced MAACE by 2.2% with no effect on bleeding. Both of these Korean trials were open label studies. In East Asian populations, differences in bleeding risk suggest that clopidogrel might be superior to ticagrelor, hence the decision to use it in the study. However, in other ethnic groups the same might not hold true, and whether the results would replicate with ticagrelor is anyone's guess. Guidelines Nudge but Don't Fully Budge Depending on your point of view, the accumulated data is either dizzyingly complex and impossible to parse through or too limited to make any firm recommendations. Admittedly, we have to consider not just length of DAPT but also which anti-platelets to use as monotherapy and the clinical context of the patient. A high-ischemic-risk cardiac patient at low bleeding risk is very different from a high bleeding risk patient going for an elective PCI (percutaneous coronary intervention). We shouldn't blithely assume that what's true for clopidogrel is true for ticagrelor or that one antiplatelet is universally better in all populations. Also, most trials fail to consider one important consideration: cost. Given all the new data from the last few years, you might think that clinical guidelines have evolved to incorporate or at least acknowledge the growing equipoise of how and when to inhibit platelets in cardiac patients. But the recent 2025 ACS guidelines still suggest a minimum 12 months of DAPT and give it a class 1A indication if the patient isn't at high bleeding risk. If they are, bleeding reduction strategies include transitioning to ticagrelor monotherapy after 1 month (Class 1A) and switching from ticagrelor or prasugrel to clopidogrel as part of the DAPT regimen (Class 2B). Monotherapy with any agent after 1 month also gets a 2b recommendation. Although the guidelines are starting to budge on the issue, we seem to be perpetually locked into a 12-month DAPT mindset. The why is a fascinating question. It's partly because we are often more tolerant of bleeding than of cardiovascular events. We think we can manage bleeds whereas a stent thrombosis or a recurrent myocardial infarction feels like a failure. Who follows up on the patient will also affect the duration of antiplatelet therapy. It's asking a lot of primary care providers to overrule the angiographer's recommendation of 12 months of DAPT post stent on the cath report. A combination of uncertainty and inertia is keeping 12 months of DAPT alive. I'm as guilty as everyone else of falling into long established patterns. Habits are hard to break, but 24 years after CURE, we should acknowledge that 1 year of DAPT was never shown to be clinically superior to any other interval. Most of the contemporary data suggests that shorter durations are just as good if not better.
