Intensive Arterial Pressure Control in Acute Coronary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The assessments of outcome is conducted by aninvestigator who did not participate in the randomization, protocol treatment or in-hospital clinical treatment of the patient.

Study Groups

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intensive controle group

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.

Group Type EXPERIMENTAL

Isosorbide Dinitrate

Intervention Type DRUG

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

standard control group

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.

Group Type ACTIVE_COMPARATOR

Isosorbide Dinitrate

Intervention Type DRUG

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

Interventions

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Isosorbide Dinitrate

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

Intervention Type DRUG

Other Intervention Names

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Risordan

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No