Intensive Arterial Pressure Control in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— IAPREC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135315
• Other study ID #: IAPREC
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2022
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Tunisia	university of Monastir	Monastir

Sponsors (2)

Lead Sponsor	Collaborator
University of Monastir	Emergency NGO Onlus

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	1-year death rate	12 months
Primary	major cardiovascular events (MACE)	1-year MACE rate	12months
Primary	combined mortality and MACE rate	combined mortality and MACE rate at one year.	1 year
Secondary	troponin change	troponin change between baseline and 24 hour after	24 hours after baseline measurement
Secondary	Adverse events	Severe hypotension	24 hours after start of protocol intervention

External Links

•   official department website