Acute Coronary SyndromePhase 4NCT00077818
Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)
A Phase 4 study testing Enoxaparin sodium in people with Acute Coronary Syndrome, run by Sanofi.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Enoxaparin sodium
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2002to Feb 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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:
Show all 29Show fewer
- 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
About this study
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
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
- Being tested
- Enoxaparin sodium
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess a composite score that considers the occurrence of all-cause mortality, non-fatal MI, or recurrent angina requiring the need for revascularization
Measured: up to 30 days (± 2 days) following randomization
Secondary outcomes (5)
Incidence of major hemorrhage
Measured: during the index hospitalization
Incidence of minor hemorrhage
Measured: during the index hospitalization
Combined incidence of 30-day all-cause mortality and nonfatal MI
Measured: at 30 days
The incidence of 30-day all-cause mortality by itself
Measured: At 30 days
Total health care utilization
Measured: from baseline (initial hospitalization) through the Day 30 follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startJun 2002
- Primary completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luc Sagnard, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077818
- Sponsor's protocol ID
- XRP4563B_4001
- Status last verified
- Oct 2009
- First submitted
- 12 Feb 2004
- Last updated
- 15 Oct 2009
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00077818
- Acronym / sponsor ID
- XRP4563B_4001
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Feb 2005 (actual)
- First posted
- 16 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.)
Key exclusion criteria (29 listed)
- Increased bleeding risk as defined by any of the following:
- Impaired hemostasis including any one of the following:
- Angina from a secondary cause such as:
- Bundle branch block not known to be old in the context of angina.
- Undergone a percutaneous coronary intervention (PCI) within the past 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin sodium | Drug | – |
Primary outcome
To assess a composite score that considers the occurrence of all-cause mortality, non-fatal MI, or recurrent angina requiring the need for revascularization
Time frame: up to 30 days (± 2 days) following randomization
5 secondary outcomes
Incidence of major hemorrhage
Time frame: during the index hospitalization
Incidence of minor hemorrhage
Time frame: during the index hospitalization
Combined incidence of 30-day all-cause mortality and nonfatal MI
Time frame: at 30 days
The incidence of 30-day all-cause mortality by itself
Time frame: At 30 days
Total health care utilization
Time frame: from baseline (initial hospitalization) through the Day 30 follow-up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Sagnard study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin sodium in people with Acute Coronary Syndrome, run by Sanofi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess a composite score that considers the occurrence of all-cause mortality, non-fatal MI, or recurrent angina requiring the need for revascularization (time frame: up to 30 days (± 2 days) following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.