Intensive Arterial Pressure Control in Acute Coronary Syndrome (IAPREC)

• ClinicalTrials.gov Identifier: NCT02135315
• Recruitment Status: Completed
• First Posted: May 9, 2014
• Last Update Posted: August 10, 2022
• Sponsor: University of Monastir
• Collaborator: Emergency NGO Onlus
• Information provided by (Responsible Party): Pr. Semir Nouira, University of Monastir

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.

We 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	Not Applicable

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 (Clinical Trial)
• 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: October 2013
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 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 Name: 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 Name: Risordan

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. troponin change [ Time Frame: 24 hours after baseline measurement ]
   troponin change between baseline and 24 hour after
2. Adverse events [ Time Frame: 24 hours after start of protocol intervention ]
   Severe hypotension

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Tunisia

university of Monastir

Monastir, Tunisia, 5000

Sponsors and Collaborators

University of Monastir

Emergency NGO Onlus

Investigators

• Principal Investigator: Semir Nouira, MD; University of Monastir

More Information

Additional Information:

official department website 

• Responsible Party: Pr. Semir Nouira, professor, University of Monastir
• ClinicalTrials.gov Identifier: NCT02135315
• Other Study ID Numbers: IAPREC
• First Posted: May 9, 2014
• Last Update Posted: August 10, 2022
• Last Verified: August 2022

Keywords provided by Pr. Semir Nouira, University of Monastir:

Acute Coronary Syndrome, arterial pressure

Additional relevant MeSH terms:

Acute Coronary Syndrome; Syndrome; Disease; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Diuretics, Osmotic; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Vasodilator Agents; Nitric Oxide Donors; Molecular Mechanisms of Pharmacological Action