2024-511950-35-00招募中3 期
BIOmarker driven intensification of cardiovascular RISK factor management in patients with high risk for recurrent cardiovascular EVENTs
Medical University Of Graz29 个研究点 分布在 3 个国家目标入组 1,758 人开始时间: 2025年5月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,758
- 试验地点
- 29
- 主要终点
- Time to first event of a composite of cardiovascular outcomes encompassing - Cardiovascular death - Non-fatal myocardial infarction -Non-fatal stroke - Hospitalisation for urgent coronary revascularisation - Hospitalisation for heart failure
研究概览
简要总结
The primary objective of the randomized controlled trial is to evaluate the efficacy (in terms of a composite effect) of intensified residual risk management versus standard guideline treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Individuals > 18 years of age
- •Written consent of the participant after being informed
- •Percutaneous coronary intervention (PCI) procedure for acute myocardial infarction (inclusion window: 48 hours to 14 days after PCI)
- •BIO-RISK-EVENT score parameters available
排除标准
- •Previous myocardial infarction (prior to the current event leading to enrolment)
- •Known drug or alcohol abuse or psychiatric disorder that, in the opinion of the investigator prevents participation from following the protocol
- •Haemodynamic instability as defined by intravenous administration of catecholamines, calcium sensitisers or phosphodiesterase inhibitors
- •New York Heart Failure (NYHA) Functional Classification Class IV heart failure at baseline
- •Participation in another clinical trial that may affect the results of this study
- •Type 1 diabetes mellitus
- •eGFR <45 mL/min/1.73 m2
- •Liver cirrhosis Childs B or C or other known liver disease preventing the study candidate to participate according to the judgment of the investigator
- •Women who are pregnant or breast-feeding
- •Women of child-bearing potential
- •Treatment with ciclosporin and strong CYP3A3 inhibitors
- •Current treatment with an SGLT2 inhibitor
- •Have family (first-degree-relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •Have had a transplanted organ or awaiting an organ transplant
- •Men whose partners are capable of becoming pregnant may only participate in the clinical study if they commit to using a reliable method of contraception throughout the study duration and for at least 6 months after the end of the trial medication
- •Current treatment with colchicine
- •Current treatment with icosapent ethyl
- •Known allergy to any of the medications being used for intensified treatment or their constituents, or to medications with a similar chemical structure
- •Active known malignancies within the last year, except intraepithelial neoplasm of the prostate, gastrointestinal tract and basal cell carcinoma
- •Known history of retinopathy and/or macular oedema
- •Acute inflammatory disease (e.g. pneumonia, urinary tract infection, etc.)
- •Chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis, etc.)
结局指标
主要结局
Time to first event of a composite of cardiovascular outcomes encompassing - Cardiovascular death - Non-fatal myocardial infarction -Non-fatal stroke - Hospitalisation for urgent coronary revascularisation - Hospitalisation for heart failure
Time to first event of a composite of cardiovascular outcomes encompassing - Cardiovascular death - Non-fatal myocardial infarction -Non-fatal stroke - Hospitalisation for urgent coronary revascularisation - Hospitalisation for heart failure
次要结局
- Time to first event for cardiovascular death
- Time to all-cause mortality
- Time to first event for non-fatal myocardial infarction
- Time to first event for non-fatal stroke
- Time to first event for hospitalisation for urgent coronary revascularisation
- Time to first event for hospitalisation for heart failure
- Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Non-fatal myocardial infarction -Non-fatal stroke
- Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Hospitalisation for heart failure
- Time to first event for any urgent revascularisation procedure of a -Coronary artery -Carotid artery -Peripheral artery
- Time to first event for major adverse limb events
研究者
Prof. Harald Sourij
Scientific
Medical University Of Graz
研究点 (29)
Loading locations...
相似试验
已完成
不适用
Medical and Physiological Benefits of Reduced SittingMetabolic SyndromePhysical ActivityCardiovascular DiseasesInsulin ResistanceNCT03101228Turku University Hospital64
Unknown
不适用
Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant RadiotherapyFemale Breast CancerFatigueQuality of LifePhysiological StressComplications RadiotherapyNCT04775290Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori120
已完成
不适用
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using BiomarkersChronic Liver DiseasesCirrhosisNCT02272504Wako Life Sciences2,500
进行中（未招募）
3 期
The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA"Low Back PainNCT05544656Semmelweis University150
已完成
1 期
Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT04744636Institut de Recherches Internationales Servier100