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

NCT00718471 | Completed Phase 3 DMC

• 2 other identifiers: P071101EUDRACT: 2007-007676-42
• Study Type: interventional
• Target: 910
• Locations: 1 country
• Sites: 1

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)

Conditions

Primary PCI - STEMI

Keywords

STEMI; Primary PCI; Anticoagulation

Outcome Measures

Primary Outcomes (1)

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

  administration

Secondary Outcomes (4)

• major bleeding during hospitalization

  during hospitalization and at 6 months

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

  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.

  day 30 and 6 months

• the composite of major and minor bleeding during hospitalization

  during hospitalization and months 6

Study Arms (2)

1

EXPERIMENTAL

Enoxaparin

Drug: Enoxaparin

2

ACTIVE COMPARATOR

UFH

Drug: UFH (unfractionated heparin)

Interventions

Enoxaparin DRUG

ENOXAPARIN IV 0.5 mg.kg

1

UFH (unfractionated heparin) DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

La Pitié-Salpétrière Hospital - Cardiology department

Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 21856483 RESULT

• 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.

  PMID: 30144017 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Enoxaparin; Heparin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Gilles MONTALESCOT, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

FR (1)