Completed

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

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What is being tested

Enoxaparin sodium

Drug
Who is being recruted

Acute Coronary Syndrome

Over 18 Years
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: June 2002

Summary

Principal SponsorSanofi
Last updated: October 15, 2009
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2002Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
Principal SponsorSanofi
Last updated: October 15, 2009
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Acute Coronary Syndrome
Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers