Objectives To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients will also be evaluated. Trial design This is a single-centre, prospective, four-arm parallel design, open-label, randomized control trial. Participants The study will be conducted at National Cancer Institute (NCI), Jhajjar, Haryana, which is a part of All India Institute of Medical Sciences (AIIMS), New Delhi, and has been converted into a dedicated COVID-19 management centre since the outbreak of the pandemic. All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial. Written informed consent will be taken for all recruited patients. Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. Patients refusing to give written consent and taking drugs that are known to have a significant drug interaction with statin or aspirin [including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine] will also be excluded from the trial. Intervention and comparator In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. Atorvastatin will be prescribed as 40 mg oral tablets once daily for ten days or until discharge, whichever is earlier. The dose of aspirin will be 75 mg once daily for ten days or until discharge, whichever is earlier. All other therapies will be administered according to the institute’s COVID-19 treatment protocol and the treating physician’s clinical judgment. Main outcomes All study participants will be prospectively followed up for ten days or until hospital discharge, whichever is longer for outcomes. The primary outcome will be clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality). The secondary outcomes will be change in serum inflammatory markers (C-reactive protein and Interleukin-6), Troponin I, and creatine phosphokinase (CPK) from time zero to 5th day of study enrolment or 7th day after symptom onset, whichever is later. Other clinical outcomes that will be assessed include progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality. Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding will also be examined in the trial to assess the safety of the interventions. Randomisation The study will use a four-arm parallel-group design. A computer-generated permuted block randomization with mixed block size will be used to randomize the participants in a 1:1:1:1 ratio to group A (atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy). Blinding (masking) The study will be an open-label trial. Numbers to be randomised (sample size) As there is no existing study that has evaluated the role of aspirin and atorvastatin in COVID-19 patients, formal sample size calculation has not been done. Patients satisfying the inclusion and exclusion criteria will be recruited during six months of study period. Once the first 200 patients are included in each arm (i.e., total 800 patients), the final sample size calculation will be done on the basis of the interim analysis of the collected data. Trial Status The institutional ethical committee has approved the study protocol (Protocol version 3.0 [June 2020]). Participant recruitment starting date: 28th July 2020 Participant recruitment ending date: 27th January 2021 Trial duration: 6 months Trial registration The trial has been prospectively registered in Clinical Trial Registry – India (ICMR- NIMS): Reference no. CTRI/2020/07/026791 (registered on 25 July 2020)]. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
A 62-year-old man developed concomitant right-sided pneumothorax and pneumopericardium after undergoing implantation of a left-sided dual-chamber pacemaker. The case is reported for its rarity. The possible mechanisms and management options for this extremely rare complication are discussed.
Background Statins and aspirin have been proposed for treatment of COVID-19 because of their anti-inflammatory and anti-thrombotic properties. Several observational studies have shown favourable results. There is a need for a randomised controlled trial. Methods In this single-center, open-label, randomised controlled trial, 900 RT-PCR positive COVID-19 patients requiring hospitalisation, were randomly assigned to receive either atorvastatin 40 mg (Group A, n = 224), aspirin 75 mg (Group B, n = 225), or both (Group C, n = 225) in addition to standard of care for 10 days or until discharge whichever was earlier or only standard of care (Group D, n = 226). The primary outcome variable was clinical deterioration to WHO Ordinal Scale for Clinical Improvement ≥ 6. The secondary outcome was change in serum C-reactive protein, interleukin-6, and troponin I. Results The primary outcome occurred in 25 (2.8%) patients: 7 (3.2%) in Group A, 3 (1.4%) in Group B, 8 (3.6%) in Group C, and 7 (3.2%) in Group D. There was no difference in primary outcome across the study groups (P = 0.463). Comparison of all patients who received atorvastatin or aspirin with the control group (Group D) also did not show any benefit [Atorvastatin: HR 1.0 (95% CI 0.41–2.46) P = 0.99; Aspirin: HR 0.7 (95% CI 0.27–1.81) P = 0.46]. The secondary outcomes revealed lower serum interleukin-6 levels among patients in Groups B and C. There was no excess of adverse events. Conclusions Among patients admitted with mild to moderate COVID-19 infection, additional treatment with aspirin, atorvastatin, or a combination of the two does not prevent clinical deterioration. Trial Registry Number CTRI/2020/07/026791 (http://ctri.nic.in; registered on 25/07/2020)
What is the likely mechanism of myocardial infarction in this patient?In situ coronary artery thrombosis with spontaneous recanalisation.Epicardial coronary artery vasospasm.Coronary artery embolism.Coronary microvascular dysfunction.
Intra-atrial, intracameral or intracavitary right coronary artery (IARCA) is a rare anomaly in which a segment of the right coronary artery (RCA) courses through the right atrial chamber. Radiologically, IARCA is defined as a segment of RCA that is entirely surrounded by intracavitary contrast in all phases of the cardiac cycle. It was initially described only in post mortem specimens and during cardiac surgeries with an incidence varying between ~0.1% and 1.8% (1, 2). Although current evidence points to it being a benign and incidental anomaly, its importance lies in its identification prior to ablative procedures for arrhythmias, catheterization of the right-sided chambers, and pacemaker implantation. With the indications for patients requiring the above procedures expanding rapidly, it is imperative to identify this anomaly pre-procedurally, as the risk of injury to the intracavitary coronary arterial segment is high. The injury can be thermal damage due to proximity to the ablation tip or due to entanglement during catheterization. IARCA can be detected reliably by using computed tomography coronary angiography (CTCA) and recent studies using CTCA have consistently detected a relatively higher prevalence rate as opposed to earlier studies due to its superior and improved image resolution (3, 4). As we increasingly shift from invasive coronary angiographies to non-invasive cross-sectional modalities, their diagnosis is bound to increase. The advent of dual-source CT scanners has led to tremendous developments in the field of cardiac imaging due to their higher temporal and spatial resolution. The purpose of this study was to identify the prevalence and characteristics of IARCA in the adult population undergoing CTCA on a dual-source CT scanner. PURPOSEWe aimed to determine the prevalence rate and radiological characteristics of intra-atrial right coronary artery (IARCA) in an adult population undergoing computed tomography coronary angiography (CTCA) on a dual-source CT scanner. METHODSOverall, 7114 consecutive CTCAs acquired using a dual-source CT scanner in a high-volume, specialized cardiac care facility were retrospectively analyzed for the presence of IARCA. We scrutinized the CTCA datasets to determine the prevalence rate of IARCA and also to characterize its various imaging features including its length, depth from right atrial wall, segment involved, and presence and absence of atherosclerosis within the involved segment and in the rest of the right coronary artery (RCA). RESULTSThe prevalence of IARCA was 0.29% (21/7114) in our study population. The mean length and depth of the intra-atrial segment was 14.85 mm and 2.57 mm, respectively. The mid-RCA was the most common segment to be involved, and no significant atherosclerosis was noted either in the intra-atrial segment or the rest of the RCA. CONCLUSIONThe prevalence rate of the incidental IARCA in the adult subjects undergoing CTCA is higher than previously reported for anatomical series, as seen in our study using a dual-source scanner. This under...
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