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

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

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

Study Overview

• Status: Terminated
• Conditions: Unstable Angina
• Intervention / Treatment: Drug: enoxaparin

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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: 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.
No Intervention: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization	6 months
The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).	24 hours
The incidence of major (including non-CABG-related) and minor hemorrhage.	48 hours and 30 days
The incidence of all-cause mortality, nonfatal MI, and the combination.	30 and 180 days
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	during index hospitalization

Collaborators and Investigators

• Sponsor: Canadian Heart Research Centre
• Collaborators: Sanofi
• Investigators: Study Chair: Shaun Goodman, MD, MSc, Canadian Heart Research Centre; Principal Investigator: David Fitchett, MD, Unity Health Toronto; Study Director: Anatoly Langer, MD, MSc, Canadian Heart Research Centre; Principal Investigator: Andrew T Yan, MD, Canadian Heart Research Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: August 16, 2007
• First Submitted That Met QC Criteria: August 17, 2007
• First Posted (Estimate): August 20, 2007

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: myocardial infarction; unstable angina; hemorrhage; drug therapy; myocardial ischemia
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: CHRC-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: insufficient data