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

This study has been withdrawn prior to enrollment.
(LOGISTIC DIFFICULTIES)
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00337116
First received: June 14, 2006
Last updated: January 27, 2010
Last verified: January 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 80
Study Start Date: January 2007
Estimated Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.

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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

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00337116

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

No publications provided

Responsible Party: DORON ZAHGER, SOROKA UNIVERSITY MEDICAL CENTER
ClinicalTrials.gov Identifier: NCT00337116     History of Changes
Other Study ID Numbers: sor435006ctil
Study First Received: June 14, 2006
Last Updated: January 27, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014