Nadroparine calcium or enoxaparine in acute coronary syndrome patients suffering renal insufficiency: The nadroparin versus enoxaparin (NaVe) study design

摘要

In the general population, mild renal impairment is associated with increases risk for coronary artery disease and stroke, suggesting that cardiovascular disease begins to develop early in the natural history of renal dysfunction. Patients with renal failure are known to be at increased risk of death following acute myocardial infarction or congestive heart failure. In such sense, anticoagulation in addition to antiplatelet inhibitor drugs became the standard of care, particularly, among high risk unstable angina patients associated with a scarce side effects. The Nadroparin calcium Versus Enoxaparin (NaVe) Study will evaluate in a head to head basis the anti Xa activity reached by nadroparine or enoxaparine, both low molecular weight heparins, in patients at high risk for ischemic episodes, and renal insufficiency to eventually be undergone to angiographic diagnosis studies, and in consequence proposing the best anticoagulant strategies for these patients before being invasively treated. Patients will be randomly assigned to one of the two groups: Group 1: thirty patients will be given with subcutaneous enoxaparine injections into the abdominal wall in a dose of 0,85 mg/kg every 12 hours for a maximum of 48 hours. A saline infusion dose will be given in between. Total number of injections: 6. Group 2:Thirty patients will be receiving subcutaneous injections into the abdominal wall in a doses of 30% less in relationship with his / her body weight every 8 hours for a maximum of 48 hours. In order to achieve the goal of the study, the antiXa activity will be measure using venous blood samples taken as follows: Group 1:*Within 3rd and 4 hour of the second doses of HBPM for enoxaparine.*Within 11 th and 12 th hour next to fourth doses of enoxaparine. Group 2: *Within 3rd and 4 th hour next to 3rd doses of HBPM for the nadroparine.*Within 7th and 8th hour next to 4th doses HBPM for the nadroparine. The primary end point is to analyze during the in-hospital stay phase the stability of the anti Xa activity within the therapeutic ranges which will be estimated between 0.5 to 1.0 IU during the first 48 hours.