Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Heart Research Centre
• Collaborator: Sanofi
• Treatments: Enoxaparin

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.