Aspirin

Researchers are investigating the use of aspirin combined with a P2Y12 inhibitor, known as dual antiplatelet therapy DAPT, which is the standard treatment for patients undergoing percutaneous coronary intervention PCI with stent placement. The trial aims to compare a score-based decision-making method for determining DAPT duration against the usual care approach that does not use such risk scores. This study is a randomized, single-blind trial designed to provide direct evidence on whether using risk scores improves patient outcomes. The study will include 2788 patients aged 18 years and older who have undergone PCI with stent implantation. Participants will be randomly assigned to one of two groups an algorithm-guided DAPT duration group where therapy length is decided based on the PRECISE-DAPT score, PCI complexity, and clinical condition, or a standard-of-care group where treatment duration is left to the operators discretion. The algorithm group uses specific treatment plans based on risk scores and clinical presentation, with therapy lasting from 1 month up to 12 months followed by monotherapy. Participants will be monitored over one year to assess various outcomes including death, myocardial infarction, stroke, stent thrombosis, and bleeding events. The main measure is a composite of net adverse clinical events NACE occurring within one year. The study will also track adherence to therapy and other cardiovascular events. Safety and effectiveness will be evaluated to understand if the algorithm-guided approach better balances bleeding and ischemic risks compared to standard care.

The APPENDAGE study is a phase 4 multicenter randomized clinical trial evaluating two antithrombotic strategies after left atrial appendage closure LAAC in patients with non-valvular atrial fibrillation AF. It aims to compare aspirin alone versus aspirin combined with clopidogrel to assess their effectiveness in preventing ischemic brain lesions, which are detected by cerebrovascular MRI scans. This research addresses the challenge of balancing bleeding risk and thromboembolic risk after LAAC, a procedure recommended for stroke prevention in AF patients who cannot use oral anticoagulation. Participants receive either aspirin plus clopidogrel or aspirin alone starting on the day of the LAAC procedure and continuing for three months. The LAAC is performed using devices such as the Watchman or Amplatzer Cardiac PlugAmulet. Brain MRI scans are performed immediately after the procedure and again at three months to detect ischemic lesions. The study also includes neurological tests like the NIH Stroke Scale, Modified Rankin Score, and Montreal Cognitive Assessment to evaluate functional and cognitive impacts. During the study, participants are monitored for neurological events, bleeding complications, device-related thrombus, and treatment adherence. Assessments occur at baseline, day 1, and month 3, including MRI, neurological tests, and evaluation of systemic and cerebral events. The primary outcome is the change in ischemic lesions on brain MRI over three months. Participant involvement includes follow-up visits for clinical and cognitive assessments, with a total study duration of three months after the LAAC procedure.

Researchers are evaluating the effect of low-dose aspirin 100 mg daily on preventing gastric cancer in patients with early gastric cancer or high-grade adenoma who have undergone endoscopic resection and have a negative or eradicated Helicobacter pylori status. This randomized, placebo-controlled Phase 3 trial addresses limitations in previous studies by focusing specifically on gastric cancer prevention with appropriate sample size and follow-up. Aspirin is commonly used to reduce cardiovascular risks, and some evidence suggests it may also lower gastrointestinal cancer risk, but more targeted research is needed. Participants will be randomly assigned to receive either enteric-coated aspirin 100 mg daily or a placebo tablet for five years. This double-blind study compares the incidence of gastric cancer between the aspirin and placebo groups. The trial includes a treatment period of five years, during which participants take the assigned medication daily. The study also monitors secondary outcomes like mortality, cardiovascular events, occurrence of other cancers, gastric dysplasia, aspirin-related complications, and gastric tissue improvements. During the study, participants will undergo regular assessments including pathology reviews after endoscopic resection and monitoring for adverse events. Researchers will track the primary outcome of gastric cancer incidence throughout the treatment period. Secondary outcomes such as cardiovascular disease rates and overall survival will also be evaluated. The total participant involvement includes screening, a five-year medication period, and ongoing monitoring to assess treatment effects and safety.

Researchers are evaluating different dosing regimens of enteric-coated aspirin in patients with type 2 diabetes mellitus to understand their effects on platelet aggregation. The study aims to assess how well patients respond to aspirin and to find the regimen with the lowest number of non-responders. This phase 2, randomized, open-label pilot trial also seeks to determine the feasibility of conducting a larger, confirmatory trial in the future. Participants will first take 80 mg of enteric-coated aspirin once daily for seven days. Those who show incomplete platelet inhibition after this run-in phase will be randomly assigned to receive one of three aspirin regimens in a crossover design 162 mg once daily, 81 mg twice daily, or 40 mg chewable twice daily. Each treatment period lasts seven days, separated by at least seven days of washout. During the study, blood samples will be collected to assess platelet function and serum salicylate levels. Throughout the trial, participants will attend multiple visits for blood draws and platelet function testing using Light Transmission Aggregometry. Adherence will be tracked by pill counts and questioning at visits. The primary outcomes include measuring the rate of aspirin non-responders and evaluating the feasibility of a larger trial by tracking screening, enrollment, retention, and consent rates. Secondary outcomes assess adherence, time to complete study procedures, and platelet response to different aspirin doses and other platelet activators. Total participation may extend over several months due to treatment and washout periods.

Researchers are evaluating the use of nonsteroidal anti-inflammatory drugs NSAIDs, specifically a COX-2 inhibitor, to prevent the recurrence of urethral strictures after direct visual internal urethrotomy DVIU. Urethral strictures often result from idiopathic causes or medical procedures and have higher recurrence rates in certain conditions, such as multiple or long strictures and infections. This study aims to assess the safety and effectiveness of NSAIDs in reducing stricture recurrence following surgery. Participants will be randomly assigned to one of two groups. One group will receive DVIU followed by NSAIDs for three weeks, while the other group will receive DVIU followed by a placebo for the same duration. The study uses a single-blind design where participants do not know which treatment they receive. The treatments are given postoperatively to compare their effect on preventing stricture recurrence. During the study, participants will be monitored for urethral stricture recurrence 90 days after surgery. Additional assessments include symptom scores using the International Prostate Symptom Score IPSS, quality of life evaluations, maximum urine flow rate, and any complications occurring within 90 days postoperatively. This follow-up period allows researchers to evaluate treatment impact and safety over three months.

Researchers are studying patients with severe spontaneous intracerebral hemorrhage SSICH, a type of brain bleeding, focusing on those who are on long-term oral antiplatelet therapy LOAPT. The study aims to evaluate how emergency surgery compares to standard conservative treatment in terms of survival and safety. This registry study, called CRISIH, is ongoing and gathers data from multiple centers in China over a planned 10-year period starting in 2019, with a special interest in surgical outcomes and complications for these patients. Participants receive either emergency neurosurgery to evacuate the brain hemorrhage or conservative treatments as determined by routine clinical practice. The registry collects detailed clinical, radiological, surgical, and laboratory information about each patient. Follow-up includes assessments up to six months post-hemorrhage for mortality, as well as monitoring for surgical complications and disorders of consciousness at multiple time points post-surgery. During the study, participants health data are regularly recorded, including postoperative bleeding events and consciousness status measured by the Coma Recovery Scale-Revised at 30, 90, 180, and 365 days after surgery. The main outcome measured is total mortality from hospital admission through six months after the initial hemorrhage. The study continues to enroll and follow patients beyond the initial five years, with ongoing data collection to enhance understanding of treatment effects and safety.

Chronic hypertension affects 1 to 5% of women of childbearing age and can lead to serious complications during pregnancy, such as superimposed preeclampsia, placental abruption, intrauterine growth restriction, perinatal death, maternal death, or preterm delivery. This trial evaluates whether taking 150 mg of acetylsalicylic acid aspirin daily before 20 weeks of pregnancy can help prevent these complications in pregnant women with chronic hypertension. The study is a prospective randomized double-blind placebo-controlled trial conducted to provide clearer evidence on aspirins effectiveness in this specific population. Participants are randomly assigned to receive either aspirin 150 mg or a placebo once daily in the evening. The treatment starts immediately after randomization and continues until 35 weeks plus 6 days of gestation. Both the active drug and placebo are dispensed by the study centers pharmacy, and participants are given daily logs to record their treatment adherence. This design ensures careful monitoring and comparison of outcomes between the two groups. During the study, participants will undergo regular assessments of maternal and fetal health, including monitoring for preeclampsia, fetal growth, placental health, and timing of delivery. Researchers will measure a combined outcome of maternal and perinatal complications within 9 months, along with various secondary outcomes such as fetal development and child growth up to 4 years. Safety and treatment adherence are also tracked throughout. The total participation duration aligns with the pregnancy timeline, ensuring comprehensive observation of both mother and child.

Researchers are evaluating a new device designed to test primary hemostasis, which is the bodys natural process to stop bleeding. Current tests for bleeding risk focus on platelets or von Willebrand factor but do not fully mimic real blood flow or include the role of all blood cells. This study aims to assess the performance of this new test using whole blood under conditions similar to blood vessels with different flow types, which may help better identify bleeding risks in patients with von Willebrand factor deficiency or those on antiplatelet therapy. The study involves collecting a small amount of bloodup to four citrated tubes and one EDTA tubeeither during routine blood draws for patients or blood donation for healthy controls. Participants include patients with von Willebrand disease, major constitutional thrombopathy, or those taking antiplatelet drugs, as well as healthy blood donors. The device will be tested under venous and arterial flow conditions to evaluate how well it replicates physiological blood clotting. Participants provide blood samples once, which are then analyzed using the new device. Researchers will measure the repeatability and reproducibility of the test results in healthy controls and its ability to detect bleeding issues related to antiplatelet therapy or von Willebrand factor deficiency. The study is observational and aims to improve understanding of bleeding risk assessment. Participation involves only blood collection alongside routine tests or donation, with no additional procedures required.

Researchers are investigating how the blood clotting and platelet function change in patients with end-stage heart failure who receive mechanical circulatory support devices such as percutaneous microaxial pumps Impella, extracorporeal membrane oxygenators ECMO, or Ventricular Assist Devices VAD. The study aims to understand how these devices interact with the bloods clotting system and antithrombotic drugs to identify causes of clotting or bleeding complications and potential treatment targets. The study uses two innovative tests to evaluate platelet function the Platelet Activity State PAS assay and the Thrombin Generation Test TGT. These tests are performed at several points before device implantation to establish baseline values, early after implantation during hospital stay, throughout long-term follow-up, and when complications or therapy changes occur. Alongside these tests, standard blood parameters related to coagulation and hemolysis are measured, and device function data such as pump speed and power use are recorded. Participants are monitored for up to 24 months with evaluations at 1, 3, 6, 12, 18, and 24 months after device implantation, as well as when any adverse events happen. Researchers track changes in platelet activity, coagulation markers, device parameters, and antithrombotic therapies. The study focuses on understanding how these factors relate to post-implant complications to improve patient care and device management.

Researchers are conducting a randomized clinical trial to study acute ischemic stroke patients who have experienced hemorrhagic infarction after intravenous thrombolysis. The trial aims to explore the safety and effectiveness of starting antiplatelet therapy early in these patients. Previous research showed that hemorrhagic infarction often occurs after this treatment but is mostly asymptomatic and not linked to worse outcomes. The study compares two approaches early antiplatelet therapy with aspirin given within 24 to 48 hours after stroke onset, and delayed antiplatelet therapy started beyond 48 hours or after hemorrhagic infarction has been confirmed absorbed. The aspirin dose will be determined by the clinician. Participants are randomly assigned to one of these two groups in a double-blind design. Participants will be monitored for several outcomes including the proportion with a favorable modified Rankin scale score at 90 days, changes in hemorrhage size at 7 days, stroke severity progress by NIHSS scores, and stroke recurrence rates up to one year. The trial includes clinical assessments, imaging at 24 to 36 hours post-thrombolysis, and follow-up visits to assess recovery and safety. The study is sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University.