The STREAM Percutaneous Coronary Intervention Anticoagulant Sub-study

NCT00882635 | Completed Phase 3

• 1 other identifier: STREAMPCI
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety and efficacy of Enoxaparin and Unfractionated Heparin in St Elevation Myocardial Infarction patients undergoing primary percutaneous coronary intervention.

Conditions

Acute Myocardial Infarction

Keywords

STEMI; acute coronary syndromes; primary percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Adequacy of anticoagulation with enoxaparin (anti-Xa levels ≥ 0.5 U/ml to 1.5 U/ml) vs. unfractionated heparin (ACT - ≥200 - 250 seconds with concomitant GP IIb/IIIa antagonist and ACT - ≥250 - 350 seconds without concomitant GP IIb/IIIa antagonist).

  During Primary PCI

Secondary Outcomes (2)

• Composite of major bleeding (non-CABG), death, cardiogenic shock, and congestive heart failure

  30 days

• ECG & angiographic measures before and after primary PCI

  24 hours

Study Arms (2)

Enoxaparin

EXPERIMENTAL

Drug: enoxaparin

Unfractionated heparin

ACTIVE COMPARATOR

Drug: Unfractionated heparin

Interventions

enoxaparin DRUG

Enoxaparin 0.5 mg/kg IV bolus (Regardless of whether the investigator has chosen to initiate concomitant GP IIb/IIIa antagonist; provision for additional IV enoxaparin to be administered if elapsed time to PCI exceeds 2 hours (from original IV dose) - enoxaparin 0.25 mg/kg IV will be administered At the discretion of the treating physician, if sustained anticoagulation is required then enoxaparin subcutaneously will be administered - enoxaparin 1.0 mg/kg SQ q 12 hours. Maintenance dose adjustment for renal insufficiency - creatinine clearance \< 30 ml/min, sc enoxaparin should be administered at 1.0 mg / kg / q24 hours. No adjustment of IV dose is required in case of renal insufficiency

Enoxaparin

Unfractionated heparin DRUG

Unfractionated heparin 70 u/kg IV bolus (consistent with ASSENT 4 PCI) Baseline ACT will be draw at time of sheath insertion - With use of GP IIb/IIIa antagonist additional UFH will be administered to achieve an ACT of ≥200 - 250 seconds If IIb/IIIa is not utilized - additional UFH will be administered to achieve an ACT of ≥250-350 seconds At the discretion of the treating physician if sustained anticoagulation is required:UFH infusion 12/u/kg/hr IV infusion to commence

Unfractionated heparin

Eligibility Criteria

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

You may qualify if:

• Age equal or greater than 18 years
• Onset of symptoms of STEMI \< 3 hours prior to randomisation
• lead ECG (ST elevation will be measured from the J point) indicative of an acute STEMI: \>2 mm ST elevation across 2 contiguous precordial leads (best 2 of V1-V6) or leads I, AVL for a minimum combined total of \>4 mm ST elevation,or \>3 mm ST elevation in 2 contiguous inferior leads (best 2 of II, III, AVF) for a minimum combined total of \> 6 mm ST elevation.
• Informed consent received

You may not qualify if:

• PCI (1st balloon inflation) expected to commence \< 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the cardiac catheterization laboratory (1st balloon inflation) within 3 hours after randomisation.
• Anticipated or obvious problem with vascular access.
• Previous CABG
• Left bundle branch block or ventricular pacing.
• Patients with cardiogenic shock - Killip Class 4
• Patients with a body weight \< 55 kg (known or estimated)
• Uncontrolled hypertension, defined as blood pressure measurement \> 180/110 mm Hg (systolic BP \> 180 mm Hg and/or diastolic BP \> 110 mm Hg) confirmed on repeat measures (2 documented measurements at any time) prior to randomization.
• Known use oral anticoagulants (warfarin or coumadin) or GP IIb/IIIa antagonists within the preceding 7 days or recent administration of any IV or SC anticoagulation within 12 hours including: unfractionated heparin, enoxaparin, and/or bivalirudin.
• Active bleeding, known bleeding diathesis/disorder including thrombocytopenia or clinical diagnosis associated with increased risk of bleeding including: known active peptic ulceration and/or neoplasm with increased bleeding risk.
• Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)
• Any history of central nervous system abnormality (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e \<3 months)
• Any known history of haemorrhagic stroke or stroke of unknown origin
• Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months
• Prolonged or traumatic cardiopulmonary resuscitation (\> 10 minutes) within the past 2 weeks
• Known acute pericarditis and/or subacute bacterial endocarditis

Sponsors & Collaborators

• Robert Welsh: lead
• Sanofi: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Southlake

Newmarket, Ontario, l3y 2P9, Canada

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Acute Coronary Syndrome

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

• Robert C Welsh, MD

  University of Alberta

  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 INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: October 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

CA (2)