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

Primary Purpose

Unstable Angina

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
enoxaparin
Sponsored by
Canadian Heart Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Angina focused on measuring unstable angina, drug therapy, myocardial ischemia, myocardial infarction, hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization

Secondary Outcome Measures

The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).
The incidence of major (including non-CABG-related) and minor hemorrhage.
The incidence of all-cause mortality, nonfatal MI, and the combination.
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

Full Information

First Posted
August 16, 2007
Last Updated
January 26, 2016
Sponsor
Canadian Heart Research Centre
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00518245
Brief Title
Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)
Acronym
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Low rate of patient recruitment. Cannot achieve sample size.
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Heart Research Centre
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Angina
Keywords
unstable angina, drug therapy, myocardial ischemia, myocardial infarction, hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization
Time Frame
6 months
Title
The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).
Time Frame
24 hours
Title
The incidence of major (including non-CABG-related) and minor hemorrhage.
Time Frame
48 hours and 30 days
Title
The incidence of all-cause mortality, nonfatal MI, and the combination.
Time Frame
30 and 180 days
Title
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
Time Frame
during index hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun Goodman, MD, MSc
Organizational Affiliation
Canadian Heart Research Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Fitchett, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anatoly Langer, MD, MSc
Organizational Affiliation
Canadian Heart Research Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrew T Yan, MD
Organizational Affiliation
Canadian Heart Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
insufficient data

Learn more about this trial

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

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