Treatment of unstable angina/non-ST elevation myocardial infarction (UA/NSTEMI) MedDRA version: 9.1 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction
Conditions
Interventions
Trade Name: Arixtra 2.5 mg Injection
Pharmaceutical Form: Solution for injection
Trade Name: Heparin Sodium Injection, ADD-Vantage Vial, 2000 USP Units per mL.
Pharmaceutical Form: Concentrate for
Sponsors
GlaxoSmithKline R & D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the cohort study must meet all of the following criteria: Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitroglycerine for relief of the pain). Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms. Planned coronary angiography, with PCI if indicated, within 72 hours of enrolment where possible. At least two of the three following additional criteria: • Age = 60 years • Troponin T or I or CK-MB above the upper limit of normal for the local institution; • ECG changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation. Written informed consent dated and signed 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
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: Age < 21 years. Any contraindication to UFH or fondaparinux Contraindication for angiography or PCI at baseline Subjects requiring urgent (<120 minutes) coronary angiography as characterized by those with: • refractory or recurrent angina associated with dynamic ST-deviation • heart failure • life-threatening arrhythmias • haemodynamic instability Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (i.v. or s.c.) dose was: • = 8 hours for LMWH • =60 minutes for bivalirudin • =90 minutes for UFH Hemorrhagic stroke within the last 12 months. Indication for anti-coagulation other than ACS during the index hospitalization. Pregnancy or women of childbearing potential who are not using an effective method of contraception. Co-morbid condition with life expectancy less than 6 months. Currently receiving an experimental pharmacological agent. Revascularization procedure already performed for the qualifying event. Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI initially treated with s.c. fondaparinux and referred for early coronary angiography. ;Secondary Objective: To evaluate the net clinical benefit of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI initially treated with s.c. fondaparinux and referred for early coronary angiography. To evaluate the relative efficacy outcomes of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI patients initially treated with s.c. fondaparinux and referred for early coronary angiography. To evaluate if the bleeding and PCI-related complications associated with adjunctive UFH during PCI in UA/NSTEMI patients initially treated with s.c. fondaparinux is comparable to that observed in OASIS 5 when fondaparinux was used as the sole anticoagulant during PCI. ;Primary end point(s): The designated primary outcome is: • Composite of peri-PCI* major bleeding, minor bleeding or major vascular access site complications * Peri-PCI is defined from randomisation up to 48 hours post PCI procedure. | — |
Countries
Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed