CTRI/2015/05/005794已完成3 期
A prospective Randomised, open label, blinded endpoint (PROBE)study to Evaluate DUAL antithrombotic therapy with dabigatranetexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs.triple therapy strategy with warfarin (INR 2.0 â?? 3.0) plus clopidogrel orticagrelor and aspirin in patients with non valvular atrial fibrillation(NVAF) that have undergone a percutaneous coronary intervention(PCI) with stenting. RE-DUAL PCI - RE-DUAL PCI
Boehringer Ingelheim Pharmaceuticals0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
入选标准
- •1 Male or female patients aged 18 years and more
- •2 Patients with NVAF that have been receiving oral anticoagulant treatment (either with
- •warfarin, another VKA or other novel oral anticoagulant), or were treatment naïve prior
- •to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a
- •reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or
- •thyrotoxicosis, unless long term oral anticoagulation is planned.
- •3 Patient presenting with:
- •An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either BMS or DES)
- •Stable Coronary Artery Disease with at least one lesion eligible for PCI that was
- •successfully treated by elective PCI and stenting (either BMS or DES)
- •4 The patient must be able to give informed consent in accordance with International
- •Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local
- •legislation and/or regulations
排除标准
- •The patient must not meet any of the exclusion criteria:
- •Patients with a mechanical or biological heart valve prosthesis
- •2. Cardiogenic shock during current hospitalisation
- •3. Patients who have used fibrinolytic agents within 24 hours of randomisation that, in the
- •opinion of the Investigator, will put the patient at high risk of bleeding
- •4. Stroke within 1 month prior to screening visit
- •5. Patients, who in the opinion of the Investigator, have had major surgery within the month
- •prior to screening
- •6. Patient has received an organ transplant or is on a waiting list for an organ transplant
- •7. History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless
- •the causative factor has been permanently eliminated or repaired (e.g. by surgery)
- •8. Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the
- •opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery)
- •Major bleeding episode (reduction in the haemoglobin level of at least 2g/dL, transfusion
- •of at least two units of blood, or symptomatic bleeding in a critical area or organ)
- •including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding
- •with a decrease in the haemoglobin level of at least 5g/dL or bleeding requiring
- •transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) in one
- •month prior to screening visit
- •10. Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A
- •or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding,
- •history of prolonged bleeding after surgery/intervention)
- •11. Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced
- •thrombocytopenia (platelet count <100 ï?´ 109/L) at screening (Visit 1)
- •12. Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation)
- •<30mL/min at screening (Visit 1)
- •13. Active liver disease as indicated by at least one of the following:
- •ï?· Prior and persistent alanine aminotransferase (ALT) or Aspartate transaminase
- •(AST) or alkaline phosphatase (AP) >3 ï?´ upper limit of normal (ULN)1
- •ï?· Known active hepatitis C
- •ï?· Known active hepatitis B
- •ï?· Known active hepatitis A
- •14. Recent malignancy or radiation therapy (<=6 months) unless, in the opinion of the
- •Investigator, the estimated life expectancy is greater than 36 months
- •15. Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole,
- •cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. Johnâ??s
- •Wort. See Section 4.2.2
- •16. Patients who, in the Investigatorâ??s opinion, need continuous treatment with Non-Steroidal
- •Anti-Inflammatory Drugs (NSAIDs)
- •17. Patients with a known allergy to dabigatran etexilate or to the excipients used for the
- •capsule of the drug
- •18. Patients with a known allergy to warfarin tablets or to the excipients
- •19. Patients who, in the Investigatorâ??s opinion, should not be treated with OAC
- •20. Patients with a contraindication to clopidogrel, ticagrelor or ASA
- •Pre-menopausal women (last menstruation <=1 year prior to screening) who:
- •ï?· Are pregnant or br
研究者
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