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< clinical trials / IDEAL

Study title:
Ischemia Driven Enoxaparin therapy in ACS presenting as Low risk

Status: CLOSED

Clinical Trial Registration:
clinicaltrials.gov registration number: NCT00518245

Brief description:  
IDEAL is a prospective, randomized, open label, multicenter study in low-to-moderate-risk patients presenting to the emergency department with an acute chest pain syndrome, no evidence of ST segment elevation or any other ECG changes suggestive of acute ischemia, no elevation of markers of cardiac necrosis (cardiac troponin [cTnI or cTnT] and/or creatine kinase myocardial band isoenzyme [CK-MB]), but clinical criteria indicating ischemia. Eligible subjects will be randomized (1:1 ratio) to receive either anticoagulation with the low molecular weight heparin (LMWH) enoxaparin or no enoxaparin. Both treatment groups will be given aspirin (162-325 mg first dose, and 81-325 mg/daily thereafter) or clopidogrel (75 mg dose, reserved only for subjects with allergy or other contraindication to aspirin). All other concomitant medications and treatments will be consistent with the standard of care and left to the discretion of the treating physician.

Approximately 400 patients will be enrolled at approximately 20 sites in Canada. The primary efficacy endpoint is a composite of myocardial ischemia detected by 48-hour continuous ECG monitoring or standard 12-lead ECG, all-cause mortality, nonfatal myocardial infarction (MI), or ischemia-driven revascularization at 30 days following randomization. Patients will be subsequently followed to a 6-month endpoint. .

Inclusion criteria:
Subjects meeting all of the following criteria will be considered for
enrollment into the study

• 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 (e.g., chest pain score 10; see Appendix A); 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 the following high-risk clinical features:

• 2 episodes of angina within the previous 24 hours;
• age 65 years;
• diabetes mellitus treated with oral anti-hyperglycemic agent or insulin;
• 3 cardiovascular risk factors (family history of coronary artery disease, hypertension, dyslipidemia, diabetes mellitus, current smoker);
• prior PCI or angiographic evidence of coronary artery disease (at least 1 coronary stenosis 50%);
• history of heart failure diagnosed by a physician or requiring hospitalization;
peripheral arterial disease, defined as intermittent claudication, documented decreased pulses or bruit supported by an abnormal ankle-brachial index
• < 0.90, or diagnosis on duplex ultrasound;
• ASA use within past 7 days.
• Informed consent must be obtained in writing for all subjects at enrollment
into the study. 

Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
Clear indication for low molecular weight or unfractionated heparin, including:

• ST depression or elevation ≥ 0.5 mm in two or more contiguous leads;
• T wave inversion ≥ 2 mm in two or more contiguous leads;
• troponin I or T > normal;
• Hypotension (systolic blood pressure <100 mmHg) or congestive heart failure on presentation (Killip class ≥ 2);
• History of unstable angina, MI, or coronary revascularization within the previous 6 months;
• Thrombolytic or oral anticoagulant or any heparin therapy within the preceding 24 hours;
• baseline aspirin use is not an exclusion criterion but baseline clopidogrel use is an exclusion criterion.
• Pregnancy (by history, or positive serum or urine pregnancy test).
• Informed consent must be obtained in writing for all subjects at enrollment
into the study. 

Increased bleeding risk as defined by any of the following:

• Pericarditis;
• Ischemic stroke within the past 12 months;
• Any previous hemorrhagic stroke, tumor, or intracranial aneurysm;
• Recent (<1 month) trauma or major surgery (including bypass surgery);
• Recent (<3 months) spinal surgery;
• A recent (<48 hours) or planned spinal/epidural anesthesia or puncture;
• Active bleeding (other than minor skin abrasions).

Impaired hemostasis, including any one of the following:

• Known International Normalized Ratio (INR) >1.5;
• Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders);
• Know or history of thrombocytopenia (platelet count 100 x 109/L [<100,000/mm3]);
• History of thrombocytopenia with glycoprotein IIb/IIIa inhibitor therapy, heparin, or enoxaparin.

Angina from a secondary cause, including:

• severe, uncontrolled hypertension (systolic blood pressure >180 mmHg despite treatment);
• significant anemia defined as hemoglobin < 110 g/L for men, < 90 g/L for women;
• valvular disease;
• congenital heart disease;
• hypertrophic or restrictive cardiomyopathy;
• hypertrophic or restrictive cardiomyopathy;
• thyrotoxicosis; illicit drug use (e.g. cocaine).
• Inability to commence ST segment monitoring within 4 hours
of study drug initiation.
• Uninterpretable ST segment based upon baseline 12-lead ECG (e.g. left bundle branch block (LBBB), left ventricular hypertrophy (LVH) with strain, digoxin effect, atrial fibrillation, etc.).
• 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 (please refer to Appendix B for upper cutoff of serum creatinine level).
• A prosthetic heart valve.
• Any other clinically relevant serious diseases, including severe liver disease, active cancer, sepsis or other serious acute infection, brain ischemia; rendering implementation of the protocol or interpretation of the study results difficult.
• 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 (e.g., has uncooperative attitude, inability to return for follow-up visits).
• Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent

Sponsors and collaborators:

Canadian Heart Research Centre
Sanofi -Aventis U.S. Inc.

Principal Co-Investigators:

Dr. David Fitchett, MD
St. Michael's Hospital, Toronto

Dr. Shaun Goodman, MD, MSc
Canadian Heart Research Centre

Study Chairman:
Dr. Anatoly Langer, MD, MSc  
Canadian Heart Research Centre