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

Unstable Angina Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00518245
• Other study ID #: CHRC-022
• Status: Terminated
• Phase: Phase 4
• First received: August 16, 2007
• Last updated: January 26, 2016
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: January 2016
• Source: Canadian Heart Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Unstable Angina

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Heart Research Centre	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization		30 days	Yes
Secondary	The incidence of, and time to, the composite endpoint of death, nonfatal MI, recurrent myocardial ischemia, or need for coronary revascularization		6 months	No
Secondary	The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).		24 hours	No
Secondary	The incidence of major (including non-CABG-related) and minor hemorrhage.		48 hours and 30 days	Yes
Secondary	The incidence of all-cause mortality, nonfatal MI, and the combination.		30 and 180 days	No
Secondary	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	Yes