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

• Status: Withdrawn
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 4

Details

• Lead Sponsor: Soroka University Medical Center
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

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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