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

NCT ID: NCT00518245

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-08-31

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

Conditions

Unstable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

enoxaparin

Intervention Type: DRUG

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.

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

enoxaparin

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Canadian Heart Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anatoly Langer

Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaun Goodman, MD, MSc

Role: STUDY_CHAIR

Canadian Heart Research Centre

David Fitchett, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Anatoly Langer, MD, MSc

Role: STUDY_DIRECTOR

Canadian Heart Research Centre

Andrew T Yan, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Heart Research Centre

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CHRC-022

Identifier Type: -

Identifier Source: org_study_id