Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337116
Status:
WITHDRAWN
Last Update Posted:
2010-01-28
First Post:
2006-06-14
Brief Title:
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome ACS Patients
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome ACS Patients
Status:
WITHDRAWN
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
LOGISTIC DIFFICULTIES
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 acute anginal pain episodes in acute coronary syndrome patients in comparison with the usual manner of SL isosorbide dinitrate
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 unstable angina and consequentially causes elevation of tissue oxygen demand Control of cardiac pain is typically accomplished with a combination of oxygen analgesic eg morphine beta blockers agents and primarily nitrates
Sublingual nitrates are currently the guidelines recommended preparation for instant relief of brief episodes of pain In patients with prolonged periods of waxing and waning chest pain drip of intravenous nitrates may be of benefit in controlling of symptoms and correcting ischemia
Intravenous nitrates are also indicated for the treatment of acute decompensated CHF patients with pulmonary edema nevertheless the current treatment for these patients edema is repeated intravenous boluses of and not sublingual isosorbide dinitrate followed by continuous drip Although there is no hard data on intravenous high-dose nitrates for the relief of acute anginal pain episodes our clinical impression with this method is excellent
Intravenous boluses of isosorbide dinitrate in a hospital setting provides immediate accurate bioavailability and is an easily controlled modality for providing nitrates
Since intravenous boluses of isosorbide dinitrate is the standard care for acute anginal pain episodes in our ICCU at this time a well designed comparative study for the two methods would help it to become a guideline and not a matter of choice in these cases
Sublingual nitrates are currently the guidelines recommended preparation for instant relief of brief episodes of pain In patients with prolonged periods of waxing and waning chest pain drip of intravenous nitrates may be of benefit in controlling of symptoms and correcting ischemia
Intravenous nitrates are also indicated for the treatment of acute decompensated CHF patients with pulmonary edema nevertheless the current treatment for these patients edema is repeated intravenous boluses of and not sublingual isosorbide dinitrate followed by continuous drip Although there is no hard data on intravenous high-dose nitrates for the relief of acute anginal pain episodes our clinical impression with this method is excellent
Intravenous boluses of isosorbide dinitrate in a hospital setting provides immediate accurate bioavailability and is an easily controlled modality for providing nitrates
Since intravenous boluses of isosorbide dinitrate is the standard care for acute anginal pain episodes in our ICCU at this time a well designed comparative study for the two methods would help it to become a guideline and not a matter of choice in these cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None