EUCTR2023-000135-76-PL招募中1 期
Therapeutic Equivalence Study of Twice Daily Acetylsalicylic Acid Tablets 50 mg Compared to Once Daily Acetylsalicylic Acid Tablets 100 mg in Adult Patients Coronary Artery Disease (CAD) or Symptomatic Peripheral Artery Disease (PAD) or after Acute Coronary Syndrome (ACS) - ACE-01-22
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.diagnosis of coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) or recent occurrence of acute coronary syndrome (ACS);
- •2.age of =18 years old;
- •3.patients who were prescribed ASA EC tablets 100 mg or ASA IR tablets 100 mg or ASA EC tablets 75 mg or ASA IR tablets 75 mg and in the opinion of the Principal Investigator
- •can be switched to ASA IR tablets 100 mg.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.blood disorders;
- •2.aspirin resistance (>550 ARU on VerifyNow® Aspirin Test);
- •3.patients treated with oral anticoagulants, thrombolytic agents, non-steroidal anti-inflammatory drugs in the period <7 days before randomization
- •4.patients treated with heparin (including perioperative heparin) in the period <1 day before randomization and during the course of the study
- •5.indication for the use of low-molecular-weight heparin (LMWH)
- •6.concurrent administration of drugs that are potent inhibitors of Cytochrome P450 3A (CYP 3A)
- •7.recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist;
- •8.history of gastrointestinal bleeding within the last 6 months;
- •9.history of cerebrovascular accident within the last 3 months;
- •10.active bleeding or hemodynamic instability;
- •11.any active malignancy recent surgery (within one month) including central nervous system (CNS) surgeries like lumbar puncture;
- •12.baseline ALT >2.5 times the upper limit of normal;
- •13.platelet count =600 × 103/ mm3 or =150 × 103/mm3;
- •14.hematocrit =50% or =25%;
- •15.low compliance before enrolment;
- •16.uncontrolled diabetes mellitus (stable drug doses within last 3 months before randomization);
- •17.end stage kidney disease with glomerular filtration rate
- •<15 mL/min or on hemodialysis;
- •18.pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception e.g., intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1;
- •19.renal artery stenosis or kidney transplantation;
- •20.hypersensitivity to any component of the investigational products;
- •21.chronic liver disease;
- •22.concomitant or previous treatment with any other investigational drug within 20 days of enrolment;
- •23.as per the Investigator (or his designee) judgment, subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason).
研究者
相似试验
招募中
3 期
A comparative study on the effects of oral N-acetylcystein and Pregabalin on the blood level of oxidative stress biomarkers in patients with painful diabetic neuropathy.IRCT20180814040795N2Hamedan University of Medical Sciences140
尚未招募
3 期
Efficacy of oral NAC and rectal indomethacin in prevention pancreatitis after ERCPIRCT20201222049798N1Ahvaz University of Medical Sciences280
已完成
2 期
Comparing therapeutic efficacy of N-acetyl cysteine with the combination of N-acetyl cysteine and Cimetidine in acute acetaminophen toxicityAcute acetaminophen toxicity.Poisoning by drugs, medicaments and biological substancesT36, T37,IRCT2013102915204N1Vice chancellor for research, Mashhad University of Medical Sciences30
已完成
不适用
Clinical benefits of twice daily medication of Aclidinium Bromide Compared with once daily medication of Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Patients diagnosed with COPD in accordance to the GOLD guidelinesJPRN-UMIN000020020Kamei Internal Medicine and Respiratory Clinic60
已完成
3 期
Therapeutic effect of oral NAC on SinusitisIRCT138806112406N1Research managment center of Bushehr University of Medical Sciences45