Intensive Arterial Pressure Control in Acute Coronary Syndrome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02135315

Acronym

IAPREC

Enrollment

1500

Registered

2014-05-09

Start date

2014-03-31

Completion date

2020-12-31

Last updated

2022-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome, arterial pressure

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.

Interventions

DRUGIsosorbide 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Eligibility

Sex/Gender

ALL

Age

30 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
mortality	12 months	1-year death rate
major cardiovascular events (MACE)	12months	1-year MACE rate
combined mortality and MACE rate	1 year	combined mortality and MACE rate at one year.

Secondary

Measure	Time frame	Description
troponin change	24 hours after baseline measurement	troponin change between baseline and 24 hour after
Adverse events	24 hours after start of protocol intervention	Severe hypotension

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026