- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135315
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Monastir, Tunisia, 5000
- University of Monastir
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed.
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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:
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Active Comparator: standard control group
The 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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: 12 months
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1-year death rate
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12 months
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major cardiovascular events (MACE)
Time Frame: 12months
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1-year MACE rate
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12months
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combined mortality and MACE rate
Time Frame: 1 year
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combined mortality and MACE rate at one year.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
troponin change
Time Frame: 24 hours after baseline measurement
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troponin change between baseline and 24 hour after
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24 hours after baseline measurement
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Adverse events
Time Frame: 24 hours after start of protocol intervention
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Severe hypotension
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24 hours after start of protocol intervention
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Nitric Oxide Donors
- Isosorbide
- Isosorbide Dinitrate
- Isosorbide-5-mononitrate
Other Study ID Numbers
- IAPREC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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