A prospective, randomized, verum controlled, open label, parallel group multi-center phase III clinical trial to demonstrate the superiority of 500 or 250 mg Aspirin® i.v. (BAY 81-8781) treatment versus 300 mg Aspirin® N tablets p.o. (BAY e4465A) in patients with Acute Coronary Syndrome, measured by time dependent thromboxane inhibition - ACUTE: Intravenous Aspirin in the Treatment of ACUTe Coronary SyndromE

Bayer HealthCare AG0 个研究点目标入组 264 人开始时间: 2009年7月2日最近更新: 2015年7月10日

适应症

试验速览

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•- Age > 18 years (pre-menopausal women must apply appropriate contraception, such as oral contraception or
•intra-uterine device or be hysterectomized)
•- Baseline sample for TBX2 measurement is available
•- Caucasian patient
•- Angina pectoris lasting for more than 20 minutes within the last 24 hours before study drug treatment (or equivalent acute symptoms such as increasing dyspnoe, diaphoresis, nausea, abdominal/epigastric pain, syncope etc.)
•-and at least one of the following:
•>ECG changes suggestive for ischemia:ST elevation or T-wave change or ST depression, new or presumed LBBB
•>Elevated troponin T levels > 0.01 ng/ml or any other elevated troponin levels according to local laboratory reference values
•> Risk factors for ACS such as known coronary artery disease (CAD), diabetes mellitus, impaired renal function, peripheral artery or cerebrovascular disease, current smoking.
•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

•-Treatment with acetylsalicylic acid (ASA) within 48 hours prior to study drug treatment
•- Treatment with glycoprotein IIa/IIIb inhibitors within 48 hours prior to study drug treatment and before the 20 minutes blood samples for thromboxane, prostacycline and platelet aggregation measurement have been taken
•- Thrombolytic therapy within 24 hours before study drug treatment
•- Obligation for tracheal intubation and mechanical ventilation
•- Contraindications to ASA treatment:
•- Hypersensitivity to acetylsalicylic acid or other salicylates or to any other components of the product
•- A history of asthma or other allergic reactions induced by the administration of salicylates or substances with a
•similar action - notably non-steroidal anti-inflammatory drugs
•- Acute peptic ulcers
•- Severe uncontrolled cardiac failure
•- Combination with methotrexate at doses of 15 mg/week or more
•- Known haemorrhagic diathesis
•- Evidence of an active gastrointestinal or urogenital bleeding
•- Major surgery including coronary artery bypass graft (CABG) within 6 weeks prior to study drug treatment
•- Stroke within 3 months prior to study drug treatment
•- Known severe hepatic or renal insufficiency

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