Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337116
Recruitment Status : Withdrawn (LOGISTIC DIFFICULTIES)
First Posted : June 15, 2006
Last Update Posted : January 28, 2010
Information provided by:
Soroka University Medical Center

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 S/L isosorbide dinitrate .

Condition or disease Intervention/treatment Phase
Unstable Angina Myocardial Infarction Drug: iso sorbide dinitrate iv bolus or s/l Phase 4

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 (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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337116

Intensive Cardiac Care Unit
Beer Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: doron zahger, prof soroka university medical center israel

Responsible Party: DORON ZAHGER, SOROKA UNIVERSITY MEDICAL CENTER Identifier: NCT00337116     History of Changes
Other Study ID Numbers: sor435006ctil
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2007

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Isosorbide Dinitrate
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action