Intensive Arterial Pressure Control in Acute Coronary Syndrome
IAPREC
One-year Outcome of Intensive Versus Standard Blood Pressure Treatment in Non-ST Elevation Acute Coronary Syndrome: A Randomised Controlled Trial
1 other identifier
interventional
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 24, 2022
August 1, 2022
6.8 years
March 27, 2014
August 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
mortality
1-year death rate
12 months
major cardiovascular events (MACE)
1-year MACE rate
12months
combined mortality and MACE rate
combined mortality and MACE rate at one year.
1 year
Secondary Outcomes (2)
troponin change
24 hours after baseline measurement
Adverse events
24 hours after start of protocol intervention
Study Arms (2)
intensive controle group
EXPERIMENTALThe 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.
standard control group
ACTIVE COMPARATORThe 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Non-ST segment elevation Acute Coronary Syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Monastirlead
- Emergency NGO Onluscollaborator
Study Sites (1)
university of Monastir
Monastir, 5000, Tunisia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Semir Nouira, MD
University of Monastir
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 27, 2014
First Posted
May 9, 2014
Study Start
March 1, 2014
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
August 24, 2022
Record last verified: 2022-08