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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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


Sponsor: Canadian Heart Research Centre

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Canadian Heart Research Centre

Dates:
Date Received: August 16, 2007
Date Started: August 2007
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016