Coronary desease MedDRA version: 7.0 Level: LLT Classification code 10046251
Conditions
Interventions
Product Name: Hexadecasaccharide
Product Code: SR123781A/Sanorg123781A
Pharmaceutical Form: Solution for injection
Current Sponsor code: SR123781A/Sanorg123781A
Concentration unit: mg/ml milligram(s)/
Sponsors
Sanofi-Synthelabo-Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women older than 21 years Patients with a diagnosis of unstable angina or NSTEMI presenting with an episode of angina (with an accelerating pattern or prolonged [>20 minutes] or recurrent episodes at rest or with minimal effort) within the preceding 24 hours and for whom coronary angiography is planned and PCI is anticipated to occur in the index hospitalization and within 48 hours New ST-segment depression of = 0.1 mV or transient (less than 20 minutes) ST-segment elevation of = 0.1 mV in at least two leads on the electrocardiogram and/or elevated levels of Troponin T > 0.1 ng/ml or Troponin I > 0.2 ng/ml Patients in whom the upfront use of GPIIb/IIIa inhibitors (tirofiban or eptifibatide) before angiography is deemed not necessary Written informed consent 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: Known allergy or any contra-indication to abciximab (ReoPro®) or heparin. Administration of LMWH within 8 hours, bivalirudin, eptifibatide, tirofiban within 12 hours and abciximab (ReoPro®) within 48 hours preceding randomization. Administration of UFH within 2 hours before randomization (unless activated partial thromboplastin time [aPTT] was £50 seconds or activated clotting time [ACT] was £175 seconds at the time of randomization). Requirement for warfarin therapy. Active bleeding or increased risk of bleeding or any history of intracranial hemorrhage. History of ischemic stroke within the preceding 6 months. Poorly controlled hypertension despite antihypertensive therapy (blood pressure >180/110 mm Hg). History of clinically significant thrombocytopenia or neutropenia. Serum creatinine >2.5 mg/dl [221 µmol/L] and /or dependency on renal dialysis. Recent CABG within the previous month or known left main trunk stenosis of more than 50% severity. Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method. Administration of any investigational treatment (drug or device) in the preceding 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose effect of hexadecasaccharide (5 once daily regimens) in patients with unstable angina or non-ST-segment elevation myocardial infarction who are scheduled to undergo percutaneous coronary intervention within 48 hours;Secondary Objective: To compare the efficacy and safety between each dose of hexadecasaccharide with the active control of UFH and abciximab (ReoPro®)· To assess the effect of hexadecasaccharide on the following markers: -Post-PCI cardiac markers -Inflammatory markers -Coagulation activation markers -Coagulation tests;Primary end point(s): The primary end point of the trial is a composite of all cause death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization | — |
Countries
Spain
Outcome results
None listed