Unstable AnginaPhase 4NCT00337116
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients
A Phase 4 study testing iso sorbide dinitrate iv bolus or s/l in people with Unstable Angina and Myocardial Infarction, run by Soroka University Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unstable Angina, Myocardial Infarction
- What is being tested?
- iso sorbide dinitrate iv bolus or s/l
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
Show all 14Show fewer
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read the 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.
- Conditions
- Unstable Angina, Myocardial Infarction
- Being tested
- iso sorbide dinitrate iv bolus or s/l
- Medical subject headings
- Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iso sorbide dinitrate iv bolus or s/lDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionJan 2008 (estimated)
Why it stopped: LOGISTIC DIFFICULTIES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- doron zahger, prof, Principal investigator, soroka university medical center israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337116
- Sponsor's protocol ID
- sor435006ctil
- Status last verified
- Jan 2007
- First submitted
- 14 Jun 2006
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients
- ClinicalTrials.gov ID
- NCT00337116
- Acronym / sponsor ID
- sor435006ctil
- Conditions
- Unstable Angina, Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: LOGISTIC DIFFICULTIES
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (estimated)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iso sorbide dinitrate iv bolus or s/l | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
doron zahger, prof principal investigator
soroka university medical center israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iso sorbide dinitrate iv bolus or s/l in people with Unstable Angina and Myocardial Infarction, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2010.