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

This study has been terminated.
(Low rate of patient recruitment; low likelihood of achieving the sample size in a reasonable time frame. No safety concerns.)
Sponsor:
Collaborator:
Sanofi
Information provided by:
Canadian Heart Research Centre
ClinicalTrials.gov Identifier:
NCT00518245
First received: August 16, 2007
Last updated: August 11, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The incidence of major (including non-CABG-related) and minor hemorrhage. [ Time Frame: 48 hours and 30 days ] [ Designated as safety issue: Yes ]
  • The incidence of all-cause mortality, nonfatal MI, and the combination. [ Time Frame: 30 and 180 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: August 2007
Estimated Study Completion Date: August 2009
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Shaun Goodman, Co-Chair, CHRC, Canadian Heart Research Centre
ClinicalTrials.gov Identifier: NCT00518245     History of Changes
Other Study ID Numbers: CHRC-022
Study First Received: August 16, 2007
Last Updated: August 11, 2008
Health Authority: Canada: Health Canada

Keywords provided by Canadian Heart Research Centre:
unstable angina
drug therapy
myocardial ischemia
myocardial infarction
hemorrhage

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014