STEMI Treated With Primary Angioplasty and Intravenous Lovenox or Unfractionated Heparin (UFH)

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized evaluation of enoxaparin (0.5mg/kg IV) versus UFH (50-70IU/kg with GPIIb/IIIa inhibitors; 70-100IU without GPIIb/IIIa inhibitors). Anticoagulation can be continued after the procedure using the same agents as those allocated per randomization (enoxaparin SC, UHF IV or SC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Calcium heparin; Enoxaparin; Heparin

Criteria

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

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) 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