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Primary PCI - STEMIPhase 3ATOLLNCT00718471

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

A Phase 3 study testing Enoxaparin and UFH (unfractionated heparin) in people with Primary PCI - STEMI, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary PCI - STEMI
What is being tested?
Enoxaparin and UFH (unfractionated heparin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
910 participants
Where
1 siteFrance
Study dates
Aug 2008to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • La Pitié-Salpétrière Hospital - Cardiology department

    Paris, 75013

Other trials in France

About this study

Official title: Acute STEMI Treated With Primary Angioplasty and Intravenous 0.5 mg/kg Lovenox or UFH to Lower Ischemic and Bleeding Events

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)

Read the 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.

Being tested
Enoxaparin, UFH (unfractionated heparin)
Keywords
STEMI, Primary PCI, Anticoagulation
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoxaparinDrug

    ENOXAPARIN IV 0.5 mg.kg

  • UFH (unfractionated heparin)Drug

    UFH IV 50-70 IU if GP IIbIIIa or 70-100IU if no GP IIbIIIa

Study groups in NCT00718471
Study groupRoleWhat they receive
1ExperimentalEnoxaparin
Receives: Drug: Enoxaparin
2Active comparatorUFH
Receives: Drug: UFH (unfractionated heparin)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: administration

Secondary outcomes (4)

  1. major bleeding during hospitalization

    Measured: during hospitalization and at 6 months

  2. the ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization

    Measured: 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.

    Measured: day 30 and 6 months

  4. the composite of major and minor bleeding during hospitalization

    Measured: during hospitalization and months 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionMar 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
910 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718471
Sponsor's protocol ID
P071101
Other IDs
EUDRACT: 2007-007676-42
Acronym
ATOLL
Status last verified
Dec 2012
First submitted
16 Jul 2008
Last updated
18 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21856483

  • 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.

    PubMed 30144017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin and UFH (unfractionated heparin) in people with Primary PCI - STEMI, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality or Complications of MI or Procedure failure or Non-CABG major bleeding during hospitalization (time frame: administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718471, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.

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