Unstable AnginaPhase 4IDEALNCT00518245
Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)
A Phase 4 study testing enoxaparin in people with Unstable Angina, run by Canadian Heart Research Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective in the treatment of patients presenting to the emergency room with chest pain and no electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical features Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unstable Angina
- What is being tested?
- enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Aug 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (negative pregnancy test required for females of childbearing potential) ≥ 18 years of age and capable of signing informed consent;
- Typical chest discomfort at rest; lasting at least 5 minutes in the prior 24 hours that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray;
- Two or more of high-risk clinical features.
Who cannot join
- Clear indication for low molecular weight or unfractionated heparin;
- Pregnancy;
- Increased bleeding risk;
- Impaired hemostasis;
- Angina from a secondary cause;
- Inability to commence ST segment monitoring within 4 hours of study drug initiation;
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- Uninterpretable ST segment based upon baseline 12-lead ECG;
- Any contraindications to treatment with LMWH (or unfractionated heparin), including heparin induced thrombocytopenia, known allergy to heparin, low molecular weight heparin, pork or pork products;
- Renal insufficiency or renal dialysis;
- A prosthetic heart valve;
- Any other clinically relevant serious diseases;
- Current evidence of inebriation with alcohol or intoxication resulting from other drug abuse;
- Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or has previously enrolled in this trial;
- Inability to comply with the protocol;
- Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label, Randomized, Parallel-group Investigation to Evaluate the Efficacy and Safety of Enoxaparin Versus no Enoxaparin in Subjects With Chest Pain Syndrome and no ECG or Biomarker Abnormalities
The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective in the treatment of patients presenting to the emergency room with chest pain and no electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical features
Read the detailed description
Patients with chest pain and abnormal electrocardiogram or bloodwork (biomarker) indicative of a heart attack benefit from anticoagulant therapy such as enoxaparin. However, even patients without abnormalities on the electrocardiogram or bloodwork are at increased risk for heart attack or death, if they have certain clinical risk factors. It is currently not known whether enoxaparin is also beneficial for these patients.
Comparison: enoxaparin in addition to optimal standard care at the discretion of the treating physician, versus optimal standard care without enoxaparin
- Conditions
- Unstable Angina
- Being tested
- enoxaparin
- Keywords
- unstable angina, drug therapy, myocardial ischemia, myocardial infarction, hemorrhage
- Medical subject headings
- Angina, Unstable, Myocardial Ischemia, Myocardial Infarction, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparinDrug
Enoxaparin will be given subcutanteously at a dose of 1mg/kg every 12 hours for a minimum of 48 hours (4 doses) and a maximum of 8 days until a diagnostic / therapeutic procedure is performed, or at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: enoxaparin |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Measured: 30 days
Secondary outcomes (5)
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Measured: 6 months
The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).
Measured: 24 hours
The incidence of major (including non-CABG-related) and minor hemorrhage.
Measured: 48 hours and 30 days
The incidence of all-cause mortality, nonfatal MI, and the combination.
Measured: 30 and 180 days
One or more of the followings: hemodynamic instability, congestive heart failure, Clinical need for antithrombotic/antiplatelet therapy beyond aspirin, identifiable culprit lesion on diagnostic coronary angiography
Measured: during index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionAug 2009
Why it stopped: Low rate of patient recruitment. Cannot achieve sample size.
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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Heart Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Dr. Anatoly Langer, Canadian Heart Research Centre
- Investigators
- Shaun Goodman, MD, MSc, Study chair, Canadian Heart Research CentreDavid Fitchett, MD, Principal investigator, Unity Health TorontoAnatoly Langer, MD, MSc, Study director, Canadian Heart Research CentreAndrew T Yan, MD, Principal investigator, Canadian Heart Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518245
- Sponsor's protocol ID
- CHRC-022
- Acronym
- IDEAL
- Status last verified
- Jan 2016
- First submitted
- 16 Aug 2007
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: insufficient data
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Randomized, Parallel-group Investigation to Evaluate the Efficacy and Safety of Enoxaparin Versus no Enoxaparin in Subjects With Chest Pain Syndrome and no ECG or Biomarker Abnormalities
- ClinicalTrials.gov ID
- NCT00518245
- Acronym / sponsor ID
- IDEAL / CHRC-022
- Conditions
- Unstable Angina
- Keywords
- unstable angina, drug therapy, myocardial ischemia, myocardial infarction, hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of patient recruitment. Cannot achieve sample size.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Canadian Heart Research CentreUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Aug 2007 (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.
The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective in the treatment of patients presenting to the emergency room with chest pain and no electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical features
Detailed description
Patients with chest pain and abnormal electrocardiogram or bloodwork (biomarker) indicative of a heart attack benefit from anticoagulant therapy such as enoxaparin. However, even patients without abnormalities on the electrocardiogram or bloodwork are at increased risk for heart attack or death, if they have certain clinical risk factors. It is currently not known whether enoxaparin is also beneficial for these patients.
Comparison: enoxaparin in addition to optimal standard care at the discretion of the treating physician, versus optimal standard care without enoxaparin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: enoxaparin |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female (negative pregnancy test required for females of childbearing potential) ≥ 18 years of age and capable of signing informed consent;
- Typical chest discomfort at rest; lasting at least 5 minutes in the prior 24 hours that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray;
- Two or more of high-risk clinical features.
Key exclusion criteria (15 listed)
- Clear indication for low molecular weight or unfractionated heparin;
- Pregnancy;
- Increased bleeding risk;
- Impaired hemostasis;
- Angina from a secondary cause;
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 |
|---|---|---|
| enoxaparinEnoxaparin will be given subcutanteously at a dose of 1mg/kg every 12 hours for a minimum of 48 hours (4 doses) and a maximum of 8 days until a diagnostic / therapeutic procedure is performed, or at the discretion of the investigator. | Drug | 1 |
Primary outcome
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Time frame: 30 days
5 secondary outcomes
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Time frame: 6 months
The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).
Time frame: 24 hours
The incidence of major (including non-CABG-related) and minor hemorrhage.
Time frame: 48 hours and 30 days
The incidence of all-cause mortality, nonfatal MI, and the combination.
Time frame: 30 and 180 days
One or more of the followings: hemodynamic instability, congestive heart failure, Clinical need for antithrombotic/antiplatelet therapy beyond aspirin, identifiable culprit lesion on diagnostic coronary angiography
Time frame: during index hospitalization
Results and safety
The study was stopped early (reason given: Low rate of patient recruitment. Cannot achieve sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Individual participant dataSharing planned: No. insufficient data
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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.
Shaun Goodman, MD, MSc study chair
Canadian Heart Research Centre
David Fitchett, MD principal investigator
Unity Health Toronto
Anatoly Langer, MD, MSc study director
Canadian Heart Research Centre
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 enoxaparin in people with Unstable Angina, run by Canadian Heart Research Centre at 1 site in Canada.
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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 27 Jan 2016. 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 Canada. 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 stopped early (reason given: Low rate of patient recruitment. Cannot achieve sample size.). Results are not available in the source record.
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.
What does the primary outcome measure?
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization (time frame: 30 days). It is what the study was designed to measure, not a finding.
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 27 Jan 2016.