EUCTR2013-000055-41-GB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
- 1,217
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
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 months.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
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 ulceration
- •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
- •3) Physical and Laboratory Test Findings
- •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
- •Treatments) for therapies which are prohibited at study entry
- •b) Patients previously included or currently enrolled in clinical trials of
- •c) Required treatment
研究者
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