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Completed

NCT Number: NCT02135315

Intensive Arterial Pressure Control in Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

university of Monastir

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isosorbide Dinitrate

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Collaborators

  • Emergency NGO Onlus

Registry information

Official study title

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

Acronym: IAPREC

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 9, 2014
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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