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

NCT00337116 | Withdrawn Phase 4

• 1 other identifier: sor435006ctil
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 .

Conditions

Unstable Angina; Myocardial Infarction

Interventions

iso sorbide dinitrate iv bolus or s/l DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Intensive Cardiac Care Unit

Beersheba, Israel

Location

MeSH Terms

Conditions

Angina, Unstable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• doron zahger, prof

  soroka university medical center israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 15, 2006
• Study Start: January 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: January 28, 2010

Record last verified: 2007-01

Locations

IL (1)