Full Text View
Tabular View
No Study Results Posted
Related Studies
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients
This study is currently recruiting participants.
Study NCT00337116   Information provided by Soroka University Medical Center
First Received: June 14, 2006   Last Updated: December 15, 2008   History of Changes

June 14, 2006
December 15, 2008
January 2007
 
 
 
Complete list of historical versions of study NCT00337116 on ClinicalTrials.gov Archive Site
 
 
 
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients

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 S/L isosorbide dinitrate .

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 (e.g. 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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Unstable Angina
  • Myocardial Infarction
Drug: iso sorbide dinitrate iv bolus or s/l
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
January 2008
 

Inclusion Criteria:

  1. Age > 18 years or older.
  2. Admission to the ICCU with ACS (non-ST elevation acute coronary syndrome or 24 hours after ST elevation myocardial infarction) .
  3. Presence of ischemic symptoms (≥5 minutes) during hospitalization.
  4. 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)
  5. Willing and able to provide written informed consent according to the regulations of the Ministry of Health and the Helsinki committee instructions.

    -

Exclusion Criteria:

  1. Patient who meet any of the following criteria are excluded from the study:
  2. Persistent ST-segment elevation ≥ 1 mV in 2 or more contiguous leads or new LBBB.
  3. Acute pulmonary edema
  4. Sepsis
  5. Sustained systolic blood pressure < 90 mm Hg or evidence of cardiogenic shock
  6. Pregnant women
  7. Use at randomization of agents known to enhance the efficacy of nitrates.
  8. Clinically significant aortic stenosis
  9. Cr > 2 mg/dL
  10. Participation in another trial of an investigational drug or device on randomization.
  11. Allergy or sensitivity to nitatrate compounds
  12. Acute episode of cerebrovascular attack
  13. Inability to comply with the protocol and follow-up

    -

Both
18 Years and older
 
Contact: DORON ZAHGER, PROF. 97286403468 dzahger@bgu.ac.il
Contact: AVI SHIMONY, MD 97286400418 ashimony@bgu.ac.il
Israel
 
NCT00337116
DORON ZAHGER, SOROKA UNIVERSITY MEDICAL CENTER
sor435006ctil
Soroka University Medical Center
 
Principal Investigator: doron zahger, prof soroka university medical center israel
Soroka University Medical Center
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP