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

This study has been terminated.
(Low rate of patient recruitment. Cannot achieve sample size.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518245
First Posted: August 20, 2007
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dr. Anatoly Langer, Canadian Heart Research Centre
  Purpose
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

Condition Intervention Phase
Unstable Angina Drug: enoxaparin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. Anatoly Langer, Canadian Heart Research Centre:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T). [ Time Frame: 24 hours ]
  • The incidence of major (including non-CABG-related) and minor hemorrhage. [ Time Frame: 48 hours and 30 days ]
  • The incidence of all-cause mortality, nonfatal MI, and the combination. [ Time Frame: 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 [ Time Frame: during index hospitalization ]

Enrollment: 11
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518245


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Canadian Heart Research Centre
Sanofi
Investigators
Study Chair: Shaun Goodman, MD, MSc Canadian Heart Research Centre
Principal Investigator: David Fitchett, MD St. Michael's Hospital, Toronto
Study Director: Anatoly Langer, MD, MSc Canadian Heart Research Centre
Principal Investigator: Andrew T Yan, MD Canadian Heart Research Centre
  More Information

Responsible Party: Dr. Anatoly Langer, Chair, Canadian Heart Research Centre
ClinicalTrials.gov Identifier: NCT00518245     History of Changes
Other Study ID Numbers: CHRC-022
First Submitted: August 16, 2007
First Posted: August 20, 2007
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: insufficient data

Keywords provided by Dr. Anatoly Langer, Canadian Heart Research Centre:
unstable angina
drug therapy
myocardial ischemia
myocardial infarction
hemorrhage

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms