EUCTR2007-004301-99-BG进行中（未招募）不适用
RandomisEd Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel: Multi-centre, prospective, placebo controlled, group dose escalation trial (RE-DEEM STUDY) - RE-DEEM
Boehringer Ingelheim Pharma GesmbH0 个研究点目标入组 2,220 人开始时间: 2008年6月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,220
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. Male and female adults
- •2. Acute coronary syndrome (ACS) index event of myocardial infarction (MI)
- •MI must be documented by:
- •Detection of elevated values of cardiac biomarkers above the 99th percentile of the upper reference limit together with evidence of myocardial ischaemia with at least one of the following:
- •Ischaemic symptoms
- •ECG changes indicative of new ischaemia
- •Development of pathological Q waves in the ECG
- •3. At least one of the following criteria of higher risk
- •Age 70 years or above
- •Type I or II diabetes on treatment
- •Previous MI
- •Peripheral arterial disease, as evidenced by either previous intervention or an ankle-brachial index < 0.9
- •left bundle branch block
- •congestive heart failure requiring treatment
- •Moderate renal insufficiency creatinine clearance 30 - 60mL/min
- •No revascularisation for the index event
- •4. Ongoing treatment with dual antiplatelet therapy (ASA and clopidogrel) at the time of randomisation.
- •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. Ongoing or planned treatment with long-term oral anticoagulants for alternative indications during the course of the study (e.g. AF, prosthetic heart valves, haemodynamically relevant valve disease that is expected to require surgical intervention)
- •2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
- •3. Conditions associated with an increased risk of bleeding:
- •Major surgery (including CABG) in the previous month or scheduled for surgery during the course of the study
- •History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g.by surgery)
- •Gastrointestinal haemorrhage that resulted in hospitalisation or treatment within the past year
- •Endoscopically documented gastroduodenal ulcer disease in the previous 30 days
- •Haemorrhagic disorder or bleeding diathesis
- •Fibrinolytic agents within 48 hours of study entry
- •Uncontrolled hypertension (systolic blood pressure (SBP) > 180mmHg and/or diastolic blood pressure (DBP) > 100mmHg)
- •Recent malignancy or radiation therapy (= 6 months)
- •4. Anaemia (haemoglobin < 10g/dL) or thrombocytopenia (platelet count < 100 ? 109/L) at screening (Visit 1)
- •5. Index event is a peri-procedural Myocardial infarction at percutaneous coronary intervention or coronary artery bypass graft
- •6. If a coronary angiogram for the index event shows normal coronary arteries
- •7. Active infective endocarditis, pericarditis or pericardial effusion
- •8. Severe congestive heart failure New York Heart Association (NYHA) Class IV
- •9. Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation = 30mL/min)
- •10. Liver disease as indicated by one of the following:
- •Prior and persistent ALT > 3 X ULN, or alkaline phosphatase (Alk Phos) > 2 X ULN
- •Note: ALT elevation because of MI is not an exclusion criterion
- •Known active hepatitis C (as evidenced by positive hepatitis C virus ribonucleic acid assay by sensitive polymerase chain reaction (PCR) based assay, such as Roche Monitor or Bayer assay)
- •Active hepatitis B (HBs antigen + or anti HBc IgM+)
- •Active hepatitis A
- •11. Pre-menopausal (last menstruation = 1 year prior to screening) sexually active women who:
- •are pregnant or nursing
- •are not surgically sterile
- •are of child bearing potential and not practicing an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, double barrier or vasectomised partner)
- •12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (Visit 1)
- •13. Patients who have participated in another trial with an investigational drug or device within the last 4 weeks or 5 half-lives (whichever is greater) preceding the screening visit
- •14. Patients with a known allergy to dabigatran etexilate or to the excipients used for the capsule of the drug.
- •15. Patients also requiring chronic oral non steroidal anti inflammatory drugs (NSAIDs), chronic systemic use of corticosteroids, or any cytotoxic/myelosuppressive or immunologic drug or radiation therapy.
- •16. Patients not willing or able to comply with the protocol requirements for the duration of the study
- •17. Patients considered unreliable by the investigator concerning the require
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