EUCTR2006-003622-29-IE进行中（未招募）1 期
The ARRIVE Study (Aspirin to Reduce Risk of Initial Vascular Events) - A Randomized, Double-Blind, Placebo Controlled, Multicenter, arallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease - ARRIVE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12,000
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
- •The inclusion criteria are based on the National Heart, Lung and Blood Institute
- •(NHLBI) Framingham Heart Study (FHS) cardiovascular risk predictors.45
- •The ability of the selected inclusion criteria to procure a moderate risk population
- •was confirmed by modeling the criteria with PROCAM, Framingham and
- •SCORE risk calculators. All consenting patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •Males aged 50 years and above with 2 or 3 risk factors
- •Male Risk Factors
- •Males aged 60 and above
- •Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
- •Current smoking*: defined as any cigarette smoking in the past 12
- •months (*smoking cannot be the sole risk factor for males aged 60 and
- •Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
- •Elevated blood pressure (SBP>140 mmHg; as measured at screening)
- •Currently on any medication to treat high blood pressure
- •Positive family history of early CHD (a first-degree relative [father,
- •mother, brother, sister, son, daughter] suffered a heart attack [myocardial
- •infarction] before the age of 60 years)
- •Females aged 60 and above with 3 or more risk factors
- •Female Risk Factors
- •Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured
- •at screening)
- •Current smoking: defined as any cigarette smoking in the past 12 months
- •Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
- •Elevated blood pressure (SBP>140 mmHg; as measured at screening)
- •Currently on any medication to treat high blood pressure
- •Positive family history of early CHD (a first-degree relative [father,
- •mother, brother, sister, son, daughter] suffered a heart attack [myocardial
- •infarction] before the age of 60 years)
- •An understanding and willingness to comply with trial procedures and has
- •given written informed consent to participate in the trial
- •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
- •Patients presenting with any of the following will not be included in the trial:
- •1. Clinical history of CVD, MI, stroke, coronary artery angioplasty or stenting,
- •coronary artery bypass graft, relevant arrhythmias, or congestive heart
- •2. Patients who are at higher than moderate risk on the basis of:
- •a) their diabetes status (i.e. those with Type I or Type II diabetes
- •actively treated with drug therapy)
- •b) other factors known to the investigator (e.g. a male patient
- •over 60 years of age with 4 or more risk factors)
- •c) the currently used national risk score
- •3. Any medical condition, or psychiatric or substance abuse disorder, that, in
- •the opinion of the investigator, is likely to affect the patient’s ability to
- •complete the study or precludes the patient’s participation in the study
- •4. Lactating women or women of childbearing potential
- •5. Known increased risk of bleeding, e.g., gastric or duodenal ulcer,
- •genitourinary causes or other bleeding disorders.
- •6. Known/diagnosed reflux esophagitis.
- •7. Moderately impaired renal function based on the clinical judgment of the
- •investigator.
- •8. Severe liver disease or damage based on the clinical judgment of the
- •investigator.
- •9. A history of asthma induced by administration of salicylates or substances
- •with a similar action, notably NSAIDs
- •10. History of hypersensitivity or drug allergy to acetylsalicylic acid
- •11. A definite indication for acetylsalicylic acid therapy, other anti-platelet
- •drug, or anticoagulant in the opinion of the physician
- •12. Chronic, frequent (> 5 days/month) use of NSAIDs, COX-2 inhibitors or
- •metamizole (acetaminophen/paracetamol and other non NSAID pain
- •medications will be permitted)
- •13. Current participation in any other trials involving investigational products
- •within 30 days prior to the Screening Visit.
研究者
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