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Intensive Arterial Pressure Control in Acute Coronary Syndrome (IAPREC)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Isosorbide Dinitrate
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, arterial pressure

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • university of Monastir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intensive controle group

standard control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

troponin change
troponin change between baseline and 24 hour after
Adverse events
Severe hypotension

Full Information

First Posted
March 27, 2014
Last Updated
August 19, 2022
Sponsor
University of Monastir
Collaborators
Emergency NGO Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT02135315
Brief Title
Intensive Arterial Pressure Control in Acute Coronary Syndrome
Acronym
IAPREC
Official Title
One-year Outcome of Intensive Versus Standard Blood Pressure Treatment in Non-ST Elevation Acute Coronary Syndrome: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
Collaborators
Emergency NGO Onlus

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, arterial pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive controle group
Arm Type
Experimental
Arm Description
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.
Arm Title
standard control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Isosorbide Dinitrate
Other Intervention Name(s)
Risordan
Intervention Description
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
Primary Outcome Measure Information:
Title
mortality
Description
1-year death rate
Time Frame
12 months
Title
major cardiovascular events (MACE)
Description
1-year MACE rate
Time Frame
12months
Title
combined mortality and MACE rate
Description
combined mortality and MACE rate at one year.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
troponin change
Description
troponin change between baseline and 24 hour after
Time Frame
24 hours after baseline measurement
Title
Adverse events
Description
Severe hypotension
Time Frame
24 hours after start of protocol intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, MD
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
university of Monastir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Links:
URL
http://www.urgencemonastir.com
Description
official department website

Learn more about this trial

Intensive Arterial Pressure Control in Acute Coronary Syndrome

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