Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)
Information source: Canadian Heart Research Centre
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unstable Angina
Intervention: enoxaparin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Canadian Heart Research Centre Official(s) and/or principal investigator(s): Shaun Goodman, MD, MSc, Study Chair, Affiliation: Canadian Heart Research Centre David Fitchett, MD, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto Anatoly Langer, MD, MSc, Study Director, Affiliation: Canadian Heart Research Centre Andrew T Yan, MD, Principal Investigator, Affiliation: Canadian Heart Research Centre
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Secondary outcome: The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularizationThe incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T). The incidence of major (including non-CABG-related) and minor hemorrhage. The incidence of all-cause mortality, nonfatal MI, and the combination. 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
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Locations and Contacts
St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada
Additional Information
Starting date: August 2007
Last updated: August 11, 2008
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