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

Acute Coronary Syndrome Clinical Trial

Official title:

A Prospective, Open-label, Randomized, Parallel-group Investigation to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077818
• Other study ID #: XRP4563B_4001
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2004
• Last updated: October 14, 2009
• Start date: June 2002

Study information

• Verified date: October 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

• 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.)

EXCLUSION CRITERIA

• 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

• hypertrophic cardiomyopathy

• restrictive or constrictive cardiomyopathy

• thyrotoxicosis.

• Bundle branch block not known to be old in the context of angina.

• Undergone a percutaneous coronary intervention (PCI) within the past 24 hours.

• A known allergy to heparin, low molecular weight heparin, pork or pork products.

• Any contraindications to treatment with UFH or LMWH.

• A recent (<48 hours) or planned spinal/epidural anesthesia or puncture.

• Thrombolytic therapy within the preceding 24 hours.

• Any other clinically relevant serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min], rendering implementation of the protocol or interpretation of the study results difficult.

• 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 (e.g., has uncooperative attitude, inability to return for follow-up visits).

• Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent.

• A prosthetic heart valve

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Enoxaparin sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of major hemorrhage		during the index hospitalization	No
Secondary	Incidence of minor hemorrhage		during the index hospitalization	No
Secondary	Combined incidence of 30-day all-cause mortality and nonfatal MI		at 30 days	No
Secondary	The incidence of 30-day all-cause mortality by itself		At 30 days	No
Secondary	Total health care utilization		from baseline (initial hospitalization) through the Day 30 follow-up visit.	No