The STREAM Percutaneous Coronary Intervention Anticoagulant Sub-study

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Acute Myocardial Infarction
Interventions
DRUG

enoxaparin

"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"

DRUG

Unfractionated heparin

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

Trial Locations (2)

T6G 2B7

University of Alberta Hospital, Edmonton

l3y 2P9

Southlake, Newmarket

Sponsors
All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Boehringer Ingelheim

INDUSTRY

lead

Robert Welsh

OTHER