EUCTR2013-000055-41-DE进行中（未招募）1 期
Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) - AEGEA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,112
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
- •- Signed Written Informed Consent.
- •- Patients with diagnosed non-valvular atrial fibrillation or atrial flutter
- •(documented by 12-lead ECG or a Holter recording) and eligible for OAC
- •- Presence of at least one of the following risk factors for stroke:
- •prior stroke or transient ischaemic attack (TIA)
- •age =75 years
- •hypertension
- •diabetes mellitus
- •symptomatic heart failure (NYHA Class = II)
- •- Must be able to self-administer treatment.
- •- Either VKA treated or VKA naive.
- •VKA-treat patients must have received the VKA treatment for =3
- •VKA-naïve patients must not have received VKA treatment for more than
- •30 days within the last 12 months.
- •Patients who are not described by either of the above criteria (for
- •example, a patient treated with VKA for 40 days within the last 12
- •months) are not eligible for the study.
- •- Patients previously treated with ASA for stroke prevention are allowed
- •(and will switch to apixaban).
- •- Patients with screening Mini-mental state examination score (MMSE)
- •more than 24 (out of 30).
- •- Patient Re-enrollment: This study does not permit the re-enrollment of
- •a patient that has discontinued the study as a pre-treatment failure.
- •- Men and women = 18 years of age.
- •- Women of childbearing potential (WOCBP) must use method(s) of
- •contraception based on the tables in Appendix 3.
- •- WOCBP must have a negative urine pregnancy test (minimum
- •sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
- •the start of study medication.
- •- Women must not be breastfeeding.
- •- Men who are sexually active with WOCBP must use any contraceptive
- •method with a failure rate of less than 1% per year.
- •- Women who are not of childbearing potential (ie, who are
- •postmenopausal or surgically sterile; see Section 3.3.3 for the definition
- •of WOCBP) and azoospermic men do not require contraception.
- •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 334
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 778
排除标准
- •1) Target Disease Exceptions
- •a) Atrial fibrillation or flutter due to reversible causes (e.g.
- •thyrotoxicosis, pericarditis)
- •b) Clinically significant (moderate or severe) mitral stenosis
- •c) Cardiac valvular disease requiring surgery
- •2) Medical History and Concurrent Diseases
- •a) Conditions other than atrial fibrillation that require chronic
- •anticoagulation (e.g., prosthetic mechanical heart valve, venous
- •thromboembolism; also see Section 3.4, Concomitant Treatments).
- •b) Patient with serious bleeding in the last 6 months or with a lesion or
- •condition at high risk of bleeding such as:
- •Active peptic ulcer disease, current or recent gastrointestinal
- •Known or suspected oesophageal varices
- •Recent ischemic stroke (within 7 days)
- •Recent brain or spinal injury or intracranial haemorrhage
- •Recent brain, spinal or ophthalmic surgery
- •Arteriovenous malformations,
- •Vascular aneurysms
- •Major intraspinal or intracerebral vascular abnormalities
- •Documented hemorrhagic tendencies or blood dyscrasias
- •Presence of malignant neoplasms at high risk of bleeding
- •c) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg,
- •and/or diastolic BP > 100 mm Hg)
- •d) Active infective endocarditis
- •e) Hepatic disease associated with coagulopathy and clinically relevant
- •bleeding risk
- •f) Active alcohol or drug abuse, or psychosocial reasons that make study
- •participation impractical.
- •g) Severe co-morbid condition with life expectancy = 1 year
- •a) Severe renal insufficiency (creatinine clearance must be calculated -
- •Cockroft-Gault - in all patients; any patient with a calculated creatinine
- •clearance <15 ml/min is excluded) or patients undergoing dialysis.
- •b) ALT (alanine aminotransferase) or AST (aspartate aminotransferase)
- •> 2 times upper limit of normal or a total bilirubin > 1.5 times upper
- •limit of normal (unless an alternative causative factor [e.g., Gilbert's
- •syndrome] is identified)
- •c) Haemoglobin < 9 g/dL
- •d) Platelet count < 100,000/mm3
- •4) Allergies and Adverse Drug Reaction
- •a) Allergy or adverse reaction to apixaban or any of the excipients
- •5) Sex and Reproductive Status
- •a) Women who are pregnant or breast feeding
- •b) Women of child bearing potential (WOCBP, see Section 3.3.3 for
- •definition) who are unwilling to meet the study requirements for
- •pregnancy testing or are unwilling or unable to use an acceptable
- •method to avoid pregnancy.
- •c) Sexually active fertile men not willing to use effective birth control if
- •their partners are WOCBP
- •6) Prohibited Treatments and/or Therapies
- •a) See Section 3.4.1 of the protocol (Prohibited and/or Restricted
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