Risc Optimisation- Acute cor5onary Syndrome (RiskOp-ACS)
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|ClinicalTrials.gov Identifier: NCT03619395|
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : March 21, 2019
|Condition or disease|
|Acute Coronary Syndrome Ischemic Heart Disease|
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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2023|
- Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines [ Time Frame: 12 months ]LDL cholesterol and glycosylated hemoglobin levels
- Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term. [ Time Frame: 5 years ]LDL cholesterol and glycosylated hemoglobin levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619395
|Sonia Ruiz Bustillo||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Sonia Ruiz Bustillo, MD 0034932483118 ext 3118 firstname.lastname@example.org|
|Contact: Consol Ivern Diaz 0034932483118 ext 3118 email@example.com|