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Intensive Arterial Pressure Control in Acute Coronary Syndrome (IAPREC)

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ClinicalTrials.gov Identifier: NCT02135315
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : July 27, 2021
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 Drug: Labetalol or nicardipine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of an Intensive Arterial Pressure Control in Acute Coronary Syndrome
Actual Study Start Date : October 2013
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


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 Isosorbide Dinitrate (RISORDON) perfusion associated, if needed, with Labetalol (TRANDATE) continuous perfusion.
Drug: Isosorbide Dinitrate

continuous infusion of Isosorbide dinitrate (40 mg per 40 ml) depending on the systolic blood pressure value.

SBP: under 120 mmHg : no drug SBP: 120 to 130: 1 mg per hour SBP: 130 to 140: 2 mg per hour SBP: 140 to 150: 3 mg per hour SBP: 150 to 160: 4 mg per hour SBP: above 160 mmHg : 6 mg per hour

Other Name: RISORDAN

Drug: Labetalol or nicardipine
continuous infusion of Labetalol (Trandate) or Nicardipine (Loxen) are used if the arterial pressure objectives are not reached with the Isosorbide Dinitrate alone.
Other Name: Rescue antihypertensive drugs

Active Comparator: standard control group
the end point in these group was to maintain the systolic blood pressure between 120 and 140 mmHg using a continuous perfusion of Isosorbide Dinitrate (RISORDON) or other drugs depending on the physician choice.
Drug: Isosorbide Dinitrate

continuous infusion of Isosorbide dinitrate (40 mg per 40 ml) depending on the systolic blood pressure value.

SBP: under 120 mmHg : no drug SBP: 120 to 130: 1 mg per hour SBP: 130 to 140: 2 mg per hour SBP: 140 to 150: 3 mg per hour SBP: 150 to 160: 4 mg per hour SBP: above 160 mmHg : 6 mg per hour

Other Name: RISORDAN




Primary Outcome Measures :
  1. mortality [ Time Frame: 1 month ]
    mortality at one month.

  2. mortality [ Time Frame: 6 months ]
    mortality at six months.

  3. mortality [ Time Frame: 1 year ]
    mortality at one year.


Secondary Outcome Measures :
  1. recurrence of chest pain [ Time Frame: during hospital admission ]
    chest pain recurrence was noted during patients hospital stay in emergency or cardiology departments

  2. Acute Coronary Syndrome complication [ Time Frame: during hospital admission ]
    ACS complications such as cardiogenic shock, arrythmias, conduction troubles... were noted during patients hospital stay in emergency or cardiology departments

  3. revascularisation [ Time Frame: at hospital admission and during the followup period of one year ]
    acts of revascularisation were noted for all patients during their hospital stay and over a one year followup period

  4. stroke [ Time Frame: 1 month, 6 months and 1 year period ]
    stroke events were noted for patients during the followup period of one month, six months and one year.

  5. non cardiac deaths [ Time Frame: over the 1 year followup period ]
    non cardiac deaths were investigated during the one year followup period.



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

Inclusion Criteria:

  • Acute Coronary Syndrome

Exclusion Criteria:

  • SBP under 100 mmHg or hemodynamic instability
  • complicated ACS (arrythmias, atrio-ventricular block, shock, tamponade...) or ST elevation myocardial infarction (STEMI)
  • contre indications of beta blockers (asthma, chronic obstructive pulmonary disease (COPD), glaucoma, prostatic disorders...)

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


Contacts
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Contact: Semir Nouira, Professor +21673532014 semir.nouira@rns.tn

Locations
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Tunisia
university of Monastir Recruiting
Monastir, Tunisia, 5000
Contact: Nouirahead of departement    216073532014    semir.nouira@rns.tn   
Contact: Fattouma Bourguiba University Hospital    +216 73 106 085    semir.nouira@rns.tn   
Principal Investigator: semir nouira, professor         
Sponsors and Collaborators
University of Monastir
Emergency NGO Onlus
Investigators
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Principal Investigator: Semir Nouira, MD University of Monastir
Additional Information:
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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: July 27, 2021
Last Verified: July 2021
Keywords provided by Pr. Semir Nouira, University of Monastir:
Acute Coronary Syndrome, arterial pressure
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Labetalol
Nicardipine
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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists