Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intensive Arterial Pressure Control in Acute Coronary Syndrome (IAPREC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135315
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : August 10, 2022
Sponsor:
Collaborator:
Emergency NGO Onlus
Information provided by (Responsible Party):
Pr. Semir Nouira, 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.

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.

Layout table for study information
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


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135315


Locations
Layout table for location information
Tunisia
university of Monastir
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Emergency NGO Onlus
Investigators
Layout table for investigator information
Principal Investigator: Semir Nouira, MD University of Monastir
Additional Information:
Layout table for additonal information
Responsible Party: Pr. Semir Nouira, professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02135315    
Other Study ID Numbers: IAPREC
First Posted: May 9, 2014    Key Record Dates
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:
Layout table for 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