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

Primary Purpose

Primary PCI - STEMI

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Enoxaparin
UFH (unfractionated heparin)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary PCI - STEMI focused on measuring STEMI, Primary PCI, Anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • La Pitié-Salpétrière Hospital - Cardiology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Enoxaparin

UFH

Outcomes

Primary Outcome Measures

All-cause mortality or Complications of MI or Procedure failure or Non-CABG major bleeding during hospitalization

Secondary Outcome Measures

major bleeding during hospitalization
the ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization
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.
the composite of major and minor bleeding during hospitalization

Full Information

First Posted
July 16, 2008
Last Updated
December 17, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00718471
Brief Title
STEMI Treated With Primary Angioplasty and Intravenous Lovenox or Unfractionated Heparin (UFH)
Acronym
ATOLL
Official Title
Acute STEMI Treated With Primary Angioplasty and Intravenous 0.5 mg/kg Lovenox or UFH to Lower Ischemic and Bleeding Events
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary PCI - STEMI
Keywords
STEMI, Primary PCI, Anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
910 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Enoxaparin
Arm Title
2
Arm Type
Active Comparator
Arm Description
UFH
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
ENOXAPARIN IV 0.5 mg.kg
Intervention Type
Drug
Intervention Name(s)
UFH (unfractionated heparin)
Intervention Description
UFH IV 50-70 IU if GP IIbIIIa or 70-100IU if no GP IIbIIIa
Primary Outcome Measure Information:
Title
All-cause mortality or Complications of MI or Procedure failure or Non-CABG major bleeding during hospitalization
Time Frame
administration
Secondary Outcome Measure Information:
Title
major bleeding during hospitalization
Time Frame
during hospitalization and at 6 months
Title
the ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization
Time Frame
day30 and 6 months
Title
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
Title
the composite of major and minor bleeding during hospitalization
Time Frame
during hospitalization and months 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age. Has experienced continuous ischemic (cardiac) symptoms for at least 20 minutes. 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 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) Shock patients are eligible (but not patients with prolonged cardiac arrest) 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). Agree to comply with all protocol-specified procedures, including protocol-mandated follow-up Exclusion Criteria: Use of UFH or LMWH or any other anticoagulant agent (Vit K antagonists, fondaparinux, bivalirudin) within 48 hours prior to randomization Thrombolytic therapy within the previous 48 hours Known or suspected pregnancy in women of childbearing potential History of hypersensitivity or contraindication to heparin or LMWH Contraindication to primary PCI or any excessive bleeding risk (e.g. recent surgery) or suspected active internal bleeding Coexistent condition associated with a limited life expectancy at short term (e.g. advanced cancer) Prolonged (> 10 minutes) cardiopulmonary resuscitation (CPR) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles MONTALESCOT, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Pitié-Salpétrière Hospital - Cardiology department
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21856483
Citation
Montalescot G, Zeymer U, Silvain J, Boulanger B, Cohen M, Goldstein P, Ecollan P, Combes X, Huber K, Pollack C Jr, Benezet JF, Stibbe O, Filippi E, Teiger E, Cayla G, Elhadad S, Adnet F, Chouihed T, Gallula S, Greffet A, Aout M, Collet JP, Vicaut E; ATOLL Investigators. Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial. Lancet. 2011 Aug 20;378(9792):693-703. doi: 10.1016/S0140-6736(11)60876-3.
Results Reference
result
PubMed Identifier
30144017
Citation
Silvain J, O'Connor SA, Yan Y, Kerneis M, Hauguel-Moreau M, Zeitouni M, Overtchouk P, Ankri A, Brugier D, Vicaut E, Ecollan P, Galier S, Collet JP, Montalescot G; ATOLL Investigators. Biomarkers of Thrombosis in ST-Segment Elevation Myocardial Infarction: A Substudy of the ATOLL Trial Comparing Enoxaparin Versus Unfractionated Heparin. Am J Cardiovasc Drugs. 2018 Dec;18(6):503-511. doi: 10.1007/s40256-018-0294-z.
Results Reference
derived

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

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