DRKS00000132招募中4 期

Randomized, Double-Blind, Placebo-Controlled Trial of 6 Months versus 12 Months Clopidogrel Therapy After Implantation Of A Drug-Eluting Stent Intracoronary Stenting and Antithrombotic Regimen:Safety And Efficacy of Six-Months Dual Antiplatelet Therapy After Drug-Eluting Stenting - ISAR-SAFE

Klinik für Herz-und KreislauferkrankungenDeutsches Herzzentrum München0 个研究点目标入组 6,000 人开始时间: 2009年6月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Patients on clopidogrel therapy at 6 months (- 1/+2 months) after DES implantation
•2. Informed, written consent by the patient

•1. Age =18 years
•2. Clinically symptoms, signs of ischemia and/or presence of angiographic lesions requiring revascularization
•3. Previous stent thrombosis
•4. DES in left main coronary artery
•5. ST-elevation and non ST-elevation myocardial infarction during the last 6 months after DES implantation
•6. Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
•7. Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
•8. Active bleeding; bleeding diathesis; history intracranial bleeding
•9. Oral anticoagulation therapy with coumarin derivatives
•10. Known allergy or intolerance to the study medications: aspirin and clopidogrel
•11. Pregnancy (present, suspected or planned) or positive pregnancy test
•12. Patient's inability to fully comply with the study protocol
•13. Enrollment in another clinical trial before reaching the primary endpoint

发起方

Klinik für Herz-und KreislauferkrankungenDeutsches Herzzentrum München