Intensive Arterial Pressure Control in Acute Coronary Syndrome

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Isosorbide Dinitrate

• Registration Number: NCT02135315
• Lead Sponsor: University of Monastir

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-09
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Non-ST segment elevation Acute Coronary Syndrome

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard control group	Isosorbide Dinitrate	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.
intensive controle group	Isosorbide Dinitrate	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.

Primary Outcome Measures

Name	Time	Method
combined mortality and MACE rate	1 year	combined mortality and MACE rate at one year.
major cardiovascular events (MACE)	12months	1-year MACE rate
mortality	12 months	1-year death rate

Secondary Outcome Measures

Name	Time	Method
troponin change	24 hours after baseline measurement	troponin change between baseline and 24 hour after
Adverse events	24 hours after start of protocol intervention	Severe hypotension

Trial Locations

Locations (1)

university of Monastir; 🇹🇳 Monastir, Tunisia