Status:
WITHDRAWN
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients
Lead Sponsor:
Soroka University Medical Center
Conditions:
Unstable Angina
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, double blind, placebo-controlled study, clinical trail designed to evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate for the relief of a...
Detailed Description
Analgesia is an important element in the management of ACS patients. Pain contributes to the heightened sympathetic activity that is particularly prominent during periods of acute STEMI, NSTEMI and un...
Eligibility Criteria
Inclusion
- Age \> 18 years or older.
- Admission to the ICCU with ACS (non-ST elevation acute coronary syndrome or 24 hours after ST elevation myocardial infarction) .
- Presence of ischemic symptoms (≥5 minutes) during hospitalization.
- Pain assessment of 3 out of 10 on Visual Analog Scale (VAS) 1 or dynamic ECG findings (ST segment deviation ≥0.05 mV or T wave inversion ≥ 0.3 mV)
- Willing and able to provide written informed consent according to the regulations of the Ministry of Health and the Helsinki committee instructions.
- \-
Exclusion
- Patient who meet any of the following criteria are excluded from the study:
- Persistent ST-segment elevation ≥ 1 mV in 2 or more contiguous leads or new LBBB.
- Acute pulmonary edema
- Sepsis
- Sustained systolic blood pressure \< 90 mm Hg or evidence of cardiogenic shock
- Pregnant women
- Use at randomization of agents known to enhance the efficacy of nitrates.
- Clinically significant aortic stenosis
- Cr \> 2 mg/dL
- Participation in another trial of an investigational drug or device on randomization.
- Allergy or sensitivity to nitatrate compounds
- Acute episode of cerebrovascular attack
- Inability to comply with the protocol and follow-up
- \-
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00337116
Start Date
January 1 2007
End Date
January 1 2008
Last Update
January 28 2010
Active Locations (1)
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1
Intensive Cardiac Care Unit
Beersheba, Israel