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

NCT00518245 | Terminated Phase 4 DMC

• 1 other identifier: CHRC-022
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Unstable Angina

Keywords

unstable angina; drug therapy; myocardial ischemia; myocardial infarction; hemorrhage

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (5)

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

  6 months

• The incidence of myocardial necrosis (as detected by elevated cardiac troponin I or T).

  24 hours

• The incidence of major (including non-CABG-related) and minor hemorrhage.

  48 hours and 30 days

• The incidence of all-cause mortality, nonfatal MI, and the combination.

  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

  during index hospitalization

Study Arms (2)

1

EXPERIMENTAL

Drug: enoxaparin

2

NO INTERVENTION

Interventions

enoxaparin DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Heart Research Centre: lead
• Sanofi: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Angina, Unstable; Myocardial Ischemia; Myocardial Infarction; Hemorrhage

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Shaun Goodman, MD, MSc

  Canadian Heart Research Centre

  STUDY CHAIR

• David Fitchett, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Anatoly Langer, MD, MSc

  Canadian Heart Research Centre

  STUDY DIRECTOR

• Andrew T Yan, MD

  Canadian Heart Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 20, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)