EUCTR2011-000504-18-DE进行中（未招募）不适用
DABI-ADP-2:IMPACT OF DABIGATRAN AND PHENPROCOUMON ON CLOPIDOGREL MEDIATED ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-2
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen0 个研究点目标入组 70 人开始时间: 2011年2月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score= 1).
- •2. INR = 1.6 at study entry
- •3. Current clopidogrel treatment
- •4. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study
- •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. Age =18 years
- •2. Cardiogenic shock
- •3. Current therapy with dabigatran, Ketoconazole, Amiodarone, Chinidin, Rifampicin, St. John's wort
- •(Johanniskraut), Verapamil or Carbamazepine
- •4. INR > 1.6
- •5. Patients with a recent thrombembolic event (severe disabling stroke in the last 6 months or any stroke in the last 14 days) and/or high thrombembolic risk (mechanical valve, pulmonary embolism, deep vein thrombosis or LV thrombus) requiring bridging therapy with either unfractionated heparin or LMWH
- •6. Contraindication for oral anticoagulation
- •7. Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection;
- •8. Severe renal insufficiency (Creatinine Clearance <30ml/min)
- •9. Moderate or severe hepatic impairment (Child-Pugh class B or C) or with elevated hepatic transaminases >2 times the upper limit of normal
- •10. Planned major surgery within the next 2 weeks with the need to discontinue antithrombotic therapy
- •11. Known allergy or intolerance to the study medications and their ingredients: dabigatran (GelborangeS), phenprocoumon
- •12. Pregnancy (present, suspected or planned) or positive pregnancy test
- •(In women with childbearing potential a pregnancy test is mandatory)
- •13. Relevant hematologic deviations: hemoglobin < 10 g/dL; platelet count < 100 x 109 cells/L or platelet count > 600 x 109 cells/L
- •14. Previous enrollment in this trial
- •15. Patient’s inability to fully comply with the study protocol
研究者
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