Intensive Arterial Pressure Control in Acute Coronary Syndrome

Study Overview
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Brief Summary
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The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term. the study compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.

Detailed Description
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Acute coronary syndrome is often associated with arterial pressure elevation which are deleterious for the heart and needs urgent intervention to lower the blood pressure to the required values, however there is no clear recommendations concerning the treatment intensity in this situation. The investigators know that high arterial pressure increases the oxygen myocardial consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce intensively this pressure.

Official Title
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One-year Outcome of Intensive Versus Standard Blood Pressure Treatment in Non-ST Elevation Acute Coronary Syndrome: A Randomised Controlled Trial

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Isosorbide Dinitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-ST segment elevation Acute Coronary Syndrome Exclusion Criteria: SBP under 90 mmHg or hemodynamic instability Complicated ACS (arrythmias, atrio-ventricular block, shock, tamponade...) or ST elevation myocardial infarction (STEMI) Patients with contraindication to nitrates and/or beta blockers

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive controle group<br>The end point in this group was to maintain the systolic blood pressure (SBP) between 110 and 120 mmHg using continuous intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed. | Drug: Isosorbide Dinitrate<br>* administration of continuous intravenous isosorbide dinitrate to obtain a SBP between 110 and 120 mmHg. After 2 hours from the start of treatment and if the blood pressure goal is not achieved, labetalol is used<br>* Other names: Risordan;|
| Active Comparator: standard control group<br>The end point in these group was to maintain the systolic blood pressure under 140 mmHg using continuous intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed. | Drug: Isosorbide Dinitrate<br>* administration of continuous intravenous isosorbide dinitrate to obtain a SBP between 110 and 120 mmHg. After 2 hours from the start of treatment and if the blood pressure goal is not achieved, labetalol is used<br>* Other names: Risordan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | 1-year death rate | 12 months | 
| major cardiovascular events (MACE) | 1-year MACE rate | 12months | 
| combined mortality and MACE rate | combined mortality and MACE rate at one year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| troponin change | troponin change between baseline and 24 hour after | 24 hours after baseline measurement | 
| Adverse events | Severe hypotension | 24 hours after start of protocol intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, arterial pressure