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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 910

Inclusion Criteria

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).

7- Agree to comply with all protocol-specified procedures, including protocol-mandated follow-up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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