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| Sponsor: | The Medicines Company |
|---|---|
| Information provided by: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00093158 |
Purpose
The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A):
| Condition | Intervention | Phase |
|---|---|---|
|
Unstable Angina Myocardial Infarction Acute Disease |
Drug: Angiomax (bivalirudin) anticoagulant |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The ACUITY Trial: A Randomized Comparison of Angiomax (Bivalirudin) Versus Heparin (Unfractionated Heparin or Enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes Without ST-Segment Elevation |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meet at least one of the following criteria for UA/NSTEMI:
Exclusion Criteria:
Absolute contraindication or allergy to:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00093158 History of Changes |
| Other Study ID Numbers: | TMC-BIV-02-08, ACUITY |
| Study First Received: | October 4, 2004 |
| Last Updated: | August 20, 2007 |
| Health Authority: | United States: Food and Drug Administration |
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Acute Coronary Syndromes |
|
Acute Disease Angina, Unstable Infarction Myocardial Infarction Acute Coronary Syndrome Disease Attributes Pathologic Processes Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms |
Ischemia Necrosis Bivalirudin Anticoagulants Heparin Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors |