Acute Coronary Syndrome Clinical Trial
Official title:
Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
This study evaluates the percentage of patients that reach the objective levels of LDL cholesterol, glycosylated hemoglobin and blood pressure recommended by clinical guidelines after an acute coronary syndrome, following strategies of pharmacological optimization based on algorithms. The investigators hypothesize that the use of algorithms designed and protocolized within a cardiac rehabilitation program after an ACS to optimize pharmacological treatment is effective and safe to improve the control of risk factors in patients with high cardiovascular risk.
Despite the evidence, lipid-lowering pharmacological intervention in secondary prevention
remains insufficient. These data are also confirmed in a study conducted in our environment
where of a total of 423 high-risk patients only 29% had an optimal control of LDL-C levels
and 36% of glycated hemoglobin levels. A possible explanation is the so-called therapeutic
inertia defined as the failure of physicians to initiate or intensify an indicated therapy.
The inadequate treatment of the risks factors in the high-risk population increases morbidity
and mortality, so it is very relevant to find strategies that improve adherence to clinical
practice guidelines.
Prospective observational study of a patient population after ACS that will be compared with
a historical cohort. All participants will give informed consent before initiating procedures
within the cardiac rehabilitation program.
Primary outcome: To analyze the percentage of patients that reach the objective levels of LDL
cholesterol and glycosylated hemoglobin recommended by clinical guidelines following
pharmacological optimization protocols based on algorithms developed for this study. These
results will be compared with the historical cohort of our hospital (usual practice)
Secondary outcome: to analyze if the results of the intensive intervention during the first
year are maintained in the long term (5 years)
Baseline clinical, analytical, echocardiographic, coronary anatomy and pharmacological
therapy data will be collected. After six weeks of lipid-lowering treatment, a first
analytical control will be carried out and, following the specific algorithm designed for
this study, oral pharmacological treatment will be adapted if the LDL-C target level is not
met. After any change in therapy, a new analytical control will be performed after 8 weeks.
Diabetic patients will also undergo a baseline analytical study, if the glycosylated
hemoglobin values are not in the range recommended by the clinical practice guidelines,
pharmacological treatment optimization will be initiated following the algorithm designed for
the study. After three months of treatment, a new control and optimization of the treatment
will be carried out according to the protocol designed.
A follow-up will be carried out after 6, 12 months and 5 years
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