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

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ClinicalTrials.gov Identifier: NCT00718471
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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)

Condition or disease Intervention/treatment Phase
Primary PCI - STEMI Drug: Enoxaparin Drug: UFH (unfractionated heparin) Phase 3

Detailed Description:

This study is a prospective, multicenter, multinational, randomized, active-control arm trial. The study population consists of subjects with ST-segment elevation MI who are randomized within 24 hours of symptom onset. Subjects presenting between 12 and 24 hours of symptom onset should present with recurrent or persisting chest pain and/or recurrent or persisting ST elevation suggesting ongoing ischemia, and an indication of primary PCI.

Approximately 850 subjects will be enrolled at approximately 50 sites in several countries including Austria, France, Germany and the United States. Informed consent will be obtained from subjects meeting all inclusion and no exclusion criteria prior to any study related procedures. Subjects will be randomized and begin treatment in the Emergency Department or in the ambulance or in the hospital room if in-patient. Eligible subjects will be randomized (1:1) to receive either UFH IV bolus (ACT-adjusted) or enoxaparin 0.50 mg/kg IV bolus without monitoring. Randomization to treatment group will be performed using an interactive voice response system (IVRS). All treatment groups will be given aspirin (160 to 500 mg/day according to local practice) and clopidogrel (300 to 900mg as loading dose according to local practice). All other concomitant medications will be consistent with local standard of care.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 910 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute STEMI Treated With Primary Angioplasty and Intravenous 0.5 mg/kg Lovenox or UFH to Lower Ischemic and Bleeding Events
Study Start Date : August 2008
Primary Completion Date : March 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Enoxaparin
Drug: Enoxaparin
ENOXAPARIN IV 0.5 mg.kg
Active Comparator: 2
UFH
Drug: UFH (unfractionated heparin)
UFH IV 50-70 IU if GP IIbIIIa or 70-100IU if no GP IIbIIIa


Outcome Measures

Primary Outcome Measures :
  1. All-cause mortality or Complications of MI or Procedure failure or Non-CABG major bleeding during hospitalization [ Time Frame: administration ]

Secondary Outcome Measures :
  1. major bleeding during hospitalization [ Time Frame: during hospitalization and at 6 months ]
  2. the ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization [ Time Frame: day30 and 6 months ]
  3. efficacy objectives are each individual ischemic endpoint of the primary objective as well as the composite ischemic end-point of death, complications of MI or procedure failure. [ Time Frame: day 30 and 6 months ]
  4. the composite of major and minor bleeding during hospitalization [ Time Frame: during hospitalization and months 6 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718471


Locations
France
La Pitié-Salpétrière Hospital - Cardiology department
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Gilles MONTALESCOT, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00718471     History of Changes
Other Study ID Numbers: P071101
EUDRACT: 2007-007676-42
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
STEMI
Primary PCI
Anticoagulation

Additional relevant MeSH terms:
ST Elevation Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Heparin
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action