Acute STEMI treated with primary angioplasty and intravenous enoxaparin orUFH to lower ischemic and bleeding events at short- and long-term follow-up. - ATO

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Randomized evaluation of enoxaparin versus unfractioned heparine (UFH) withGPIIb/IIIa inhibitors
Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment: 910
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

November 17, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\- Be at least 18 years of age.
•2\- Has experienced continuous ischemic (cardiac) symptoms for at least 20 minutes.
•3\- Has onset of symptoms of qualifying acute MI within the past 24 hours, and planned for primary PCI. Patients presenting between 12 and 24 hours of symptom onset should still have an indication for primary PCI, i.e. persistent ischemic symptom and/or persistent or recurrent ST elevation
•4\- Has an ECG indicative of an acute STEMI showing:
•\= 2 mm ST elevation in 2 or more contiguous precordial ECG leads (anterior infarction); or
•\= 1 mm ST elevation in 2 or more contiguous limb ECG leads
•(other infarction); or
•New or presumably new left bundle branch block (LBBB)
•5\- Shock patients are eligible (but not patients with prolonged cardiac arrest)
•6\- Be willing to provide informed consent (informed consent may be provided by a legally authorized representative if the patient is not able to provide it).

•1\-Use of UFH or LMWH or any other anticoagulant agent (Vit K antagonists, fondaparinux, bivalirudin) within 48 hours prior to randomization
•2\-Thrombolytic therapy within the previous 48 hours
•3\-Known or suspected pregnancy in women of childbearing potential
•4\-History of hypersensitivity or contraindication to heparin or LMWH
•5\-Contraindication to primary PCI or any excessive bleeding risk (e.g. recent surgery also including punctions in the region of the spinal canal) or suspected active internal bleeding
•6\-Coexistent condition associated with a limited life expectancy at short term (e.g. advanced cancer)
•7\-Prolonged (\> 10 minutes) cardiopulmonary resuscitation (CPR)
•8\-Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial