Clinical trial NCT00518245: Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Unstable Angina
Keywords: unstable angina
drug therapy
myocardial ischemia
myocardial infarction
hemorrhage
Lead sponsor: Canadian Heart Research Centre
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-08-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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.

Primary outcomes:
measure: The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
timeFrame: 30 days
Secondary outcomes:
measure: The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
timeFrame: 6 months
measure: The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).
timeFrame: 24 hours
measure: The incidence of major (including non-CABG-related) and minor hemorrhage.
timeFrame: 48 hours and 30 days
measure: The incidence of all-cause mortality, nonfatal MI, and the combination.
timeFrame: 30 and 180 days
measure: 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
timeFrame: during index hospitalization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Canadian Heart Research Centre
name: Shaun Goodman, MD, MSc
role: STUDY_CHAIR
affiliation: Unity Health Toronto
name: David Fitchett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Heart Research Centre
name: Anatoly Langer, MD, MSc
role: STUDY_DIRECTOR
affiliation: Canadian Heart Research Centre
name: Andrew T Yan, MD
role: PRINCIPAL_INVESTIGATOR
References: