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 operator's 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.

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.

This research aims to evaluate whether taking 150 mg of aspirin daily before 20 weeks of pregnancy can help prevent complications in pregnant women with chronic hypertension. Chronic hypertension during pregnancy can lead to serious issues like preeclampsia, placental abruption, growth problems for the baby, early birth, and death of the mother or baby. Current guidelines recommend low-dose aspirin for some pregnant women at risk, but there is limited evidence specifically for those with chronic hypertension, so this study seeks to clarify its effectiveness. Participants will be randomly assigned to take either 150 mg of aspirin or a placebo once daily in the evening, starting before 20 weeks of pregnancy and continuing until about 36 weeks gestation. The study is double-blind, meaning neither the participants nor the researchers know who receives aspirin or placebo. Both groups will follow the same schedule, and treatment adherence is tracked with a daily log. During the study, participants will be monitored for maternal and baby health outcomes including preeclampsia, fetal growth, preterm birth, placental abruption, and any deaths. The trial also measures aspirin's biological effects, side effects, and child development up to four years after birth. Study visits and assessments will occur throughout pregnancy and after delivery, with safety and treatment response carefully evaluated over time.

Researchers are evaluating a new device designed to test primary hemostasis, which is the body's 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 blood—up to four citrated tubes and one EDTA tube—either 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 blood's 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.

This research aims to evaluate the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) for preventing pain compared to treating pain as it occurs during medical abortion for pregnancies between 13 and 22 weeks at Hung Vuong Hospital. The study seeks to determine whether taking NSAIDs proactively reduces pain better than using them only when pain starts and to assess any possible side effects of NSAID use in this setting. Participants will be randomly assigned to one of two groups: one receiving prophylactic NSAID treatment before pain begins, typically using oral tablets like 400 mg Ibuprofen, and the other receiving NSAIDs on demand when pain is reported. The medication dosing and frequency will be adjusted according to the clinical protocol and participant response, with careful monitoring of pain levels, safety, and overall satisfaction during the abortion process. During the study, participants will have their pain assessed using validated scales and will be observed for any adverse reactions to the medication. Researchers will collect data from the start of the medical abortion until its completion, focusing on comparing pain relief effectiveness and safety between the two approaches. The total participation duration aligns with the abortion procedure period and related assessments.

This research aims to understand how low dose aspirin (LDA) affects immune cells during pregnancy, focusing on women at high risk for preeclampsia (PE). The study evaluates the impact of LDA on both innate immunity cells like NK cells and monocytes, and acquired immunity cells such as B and T lymphocytes. It also compares immune responses and pregnancy outcomes between women at high risk who receive aspirin and those at low risk who do not. The study is observational and includes 30 pregnant women monitored over at least 40 weeks, up to 24 months. Participants are grouped into high risk for PE, who receive daily 150 mg aspirin starting before 14 weeks gestation, and low risk who do not take aspirin. Blood samples will be taken during each trimester to analyze immune cell changes and cytokine levels. Additional samples are collected before and after aspirin use in the high-risk group. After delivery, placental tissue and umbilical cord blood will be examined for immune markers. Participants will attend prenatal consultations where blood tests are performed alongside routine care. Researchers will use advanced lab methods to measure immune cells and cytokines. Outcomes include immune cell modulation at 30 weeks and maternal health measures. The study also examines placental tissue after birth. This trial is led by Unidade Local de Saúde de Coimbra, EPE, and participation involves regular pregnancy monitoring with added blood collections and assessments.