ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
NCT ID: NCT00616460
Last Updated: 2015-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2008-02-29
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bivalirudin
Bivalirudin
Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT \< 250
Interventions
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Bivalirudin
Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT \< 250
Eligibility Criteria
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Inclusion Criteria
* Creatinin clearance rate \< 60 ml per minute
* Anemia (Hb 9-11 mg%)
* Hypertension: BP \> 180/95 mmHg but less than 210/110 m Hg
* Diabetic Pts
* Steroid treated Pts
* Recent (within 6 weeks) non major surgery
* Pts with hematological disorders associated with tendency for bleeding like Thrombocytopenia (platelets 50000-150000) included TTP;
Exclusion Criteria
* Acute STEMI (Primary PCI)\*
* Rescue angioplasty \<12h after lytic therapy\*
* Active bleeding
* S.C LMWH \< 8 hours or UFH \< 4 hours before PCI
* Using IIb /IIIa as an upstream therapy before PCI
* PCI which will be involved with obligatory IIb /IIIa therapy:
(thrombotic complication, occlusive dissection)
* INR\>1.5 on day of cathetrization
* Bolus of 600mg of Clopidogrel before PCI
* Current pregnancy or women in reproductive age without contraceptives
* Hypersensitivity to heparin or bivalirudin or its components \*(possible using IIB/IIIA)
18 Years
ALL
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Turgeman Yoav
Chief of Cardiology Department
Principal Investigators
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Yoav Turgeman, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Institute HaEmek medical center
Locations
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Heart Institute haEmek Medical Center
Afula, , Israel
Countries
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Other Identifiers
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0124-07-EMC
Identifier Type: -
Identifier Source: org_study_id
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