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

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: July 16, 2008
Last updated: December 17, 2012
Last verified: December 2012
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 Intervention Phase
Primary PCI - STEMI Drug: Enoxaparin Drug: UFH (unfractionated heparin) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • major bleeding during hospitalization [ Time Frame: during hospitalization and at 6 months ]
  • the ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization [ Time Frame: day30 and 6 months ]
  • 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 ]
  • the composite of major and minor bleeding during hospitalization [ Time Frame: during hospitalization and months 6 ]

Enrollment: 910
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Enoxaparin
Active Comparator: 2
Drug: UFH (unfractionated heparin)
UFH IV 50-70 IU if GP IIbIIIa or 70-100IU if no GP IIbIIIa

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00718471

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

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00718471     History of Changes
Other Study ID Numbers: P071101
EUDRACT: 2007-007676-42
Study First Received: July 16, 2008
Last Updated: December 17, 2012

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

Additional relevant MeSH terms:
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017