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Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction

NCT ID: NCT00123565

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.

Detailed Description

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Conditions

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Coronary Atherosclerosis

Keywords

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Hexadecasaccharide (SR123781A)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A person with a diagnosis of acute coronary syndrome who is scheduled to undergo a PCI within 48 hours.
* A person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent

Exclusion Criteria

* A person with known allergy or any contra-indication to active control.
* A person who has received heparin during more than 48 hours before inclusion in the study.
* A person treated with warfarin (oral anticoagulant).
* A person with current bleeding or recognized increased risk of bleeding or history of intracranial hemorrhage.
* A person who has had a stroke within the last 6 months.
* A person with uncontrolled hypertension despite antihypertensive therapy.
* A person with history of clinically significant reduction in blood platelets or neutrophils (white blood cells).
* A person who has laboratory evidence of significantly reduced renal function or who is dependent on renal dialysis.
* A person who has a coronary bypass performed during the previous month.
* A pregnant or nursing woman or a woman of childbearing potential (before menopause) who does not have a negative pregnancy test and does not use a reliable method of birth control.
* A person who has received any investigational treatment in the preceding month.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis

Macquarie Park, , Australia

Site Status

Sanofi-Aventis

Diegem, , Belgium

Site Status

Sanofi-Aventis

São Paulo, , Brazil

Site Status

Sanofi-Aventis

Laval, Quebec, Canada

Site Status

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Site Status

Sanofi-Aventis

Prague, , Czechia

Site Status

Sanofi-Aventis France

Paris, , France

Site Status

Sanofi-Aventis

India, , India

Site Status

Sanofi-Aventis

México, , Mexico

Site Status

Sanofi-Aventis

Gouda, , Netherlands

Site Status

Sanofi-Aventis

Warsaw, , Poland

Site Status

Sanofi-Aventis

Porto Salvo, , Portugal

Site Status

Sanofi-Aventis

Moscow, , Russia

Site Status

Sanofi-Aventis

Seoul, , South Korea

Site Status

Sanofi-aventis

Barcelona, , Spain

Site Status

Sanofi-Aventis

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Chile Czechia France India Mexico Netherlands Poland Portugal Russia South Korea Spain Turkey (Türkiye)

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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SR123781A

Identifier Type: -

Identifier Source: secondary_id

DRI5228

Identifier Type: -

Identifier Source: org_study_id