IAPREC: Intensive Arterial Pressure Control in Acute Coronary Syndrome

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT02135315

Collaborator

Emergency NGO Onlus (Other)

1,500

Enrollment

Location

Arms

Actual Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Isosorbide Dinitrate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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 Other Names: Risordan
Active Comparator: 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.	Drug: 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 Other Names: Risordan

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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

Other Names:

Risordan

Active Comparator: 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.

Drug: Isosorbide Dinitrate

Other Names:

Risordan

Outcome Measures

Primary Outcome Measures

mortality [12 months]
1-year death rate
major cardiovascular events (MACE) [12months]
1-year MACE rate
combined mortality and MACE rate [1 year]
combined mortality and MACE rate at one year.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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