EUCTR2007-000713-11-NL进行中（未招募）1 期
An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate theDiscontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) onInflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA). - DECADES
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Subjects who signed the informed consent prior to any study-related procedures.
- •2) Subjects with one or more sirolimus or paclitaxel drug-eluting stents who are
- •coming to the end of their 12 months of clopidogrel (75 mg daily) treatment.
- •3) Subjects receiving low dose ASA.
- •4) Subjects receiving a statin.
- •5) Current medication regimen (including ASA and statins) must have been stable
- •for three (3) months, i.e. no initiation of new prescription medication or change in
- •dosage of any previously initiated medication within three (3) months of entering
- •this study.
- •6) Subjects with no clinical history of diabetes mellitus.
- •7) Men and women, ages 50 years or older.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Subjects with a clinical history of diabetes mellitus.
- •2) History of alcohol or substance abuse within the past 12 months.
- •3) Any condition the Investigator believes would interfere with evaluation of the
- •subject or which could put the subject at undue risk.
- •4) Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic
- •>100mmHg) at screening.
- •5) Intolerance or contraindication to ASA or statins.
- •6) Current use or use within the past 3 months of oral anticoagulants or dipyridamole
- •or oral glucocorticoids.
- •7) Currently taking another investigational study medication or participating in a
- •non-sirolimus or non-paclitaxel drug-eluting stent study or has taken
- •investigational study medication within 30 days prior to screening visit .
- •8) Subjects who would be likely to require prohibited concomitant therapy during
研究者
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