Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)

NCT00077818 | Completed Phase 4

• 1 other identifier: XRP4563B_4001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• To assess a composite score that considers the occurrence of all-cause mortality, non-fatal MI, or recurrent angina requiring the need for revascularization

  up to 30 days (± 2 days) following randomization

Secondary Outcomes (5)

• Incidence of major hemorrhage

  during the index hospitalization

• Incidence of minor hemorrhage

  during the index hospitalization

• Combined incidence of 30-day all-cause mortality and nonfatal MI

  at 30 days

• The incidence of 30-day all-cause mortality by itself

  At 30 days

• Total health care utilization

  from baseline (initial hospitalization) through the Day 30 follow-up visit.

Interventions

Enoxaparin sodium DRUG

Eligibility Criteria

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

You may qualify if:

• Rest angina lasting at least 10 minutes that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray, occurring within 24 hours of randomization;
• TIMI risk score greater than or equal to 4 (a qualitative test for CK-MB or Troponin may be utilized for screening purposes; however, a quantitative test must still be performed.)

You may not qualify if:

• Increased bleeding risk as defined by any of the following:
• Ischemic stroke within the last year
• Any previous hemorrhagic stroke, intracranial tumor, or intracranial aneurysm
• Recent (\<1 month) trauma or major surgery (including bypass surgery)
• Active bleeding (other than minor skin abrasions)
• Impaired hemostasis including any one of the following:
• Known International Normalized Ratio (INR) \>1.5
• Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders)
• Known or history of thrombocytopenia (platelet count \<100,000/mL)
• History of thrombocytopenia with glycoprotein IIb/IIIa inhibitor therapy, heparin, or enoxaparin
• Angina from a secondary cause such as:
• severe, uncontrolled hypertension (systolic blood pressure \>180 mm Hg despite treatment)
• anemia
• valvular disease
• congenital heart disease

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

enoxaparin sodium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Luc Sagnard

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 12, 2004
• First Posted: February 16, 2004
• Study Start: June 1, 2002
• Primary Completion: February 1, 2005
• Last Updated: October 15, 2009

Record last verified: 2009-10