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Completed

NCT Number: NCT00123565

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

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.

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Key information

Conditions

Coronary Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hexadecasaccharide (SR123781A)

Drug

Primary outcomes

  1. Efficacy: composite of all causes of death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization.

Secondary outcomes

  1. Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized Dose Ranging Study of Hexadecasaccharide Including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention (SHINE)

Acronym: SHINE

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 25, 2005
Registry last updated
Aug 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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