Status:
COMPLETED
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Hematologic Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of dual antiplatelet therapy in patients with high tendency for bleeding during urgent and elective PCI.
Eligibility Criteria
Inclusion
- Inclusion criteria (any of the following):
- ≥75 years
- 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
- Exclusion criteria:
- Age \< 18 year
- 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)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00616460
Start Date
February 1 2008
End Date
October 1 2011
Last Update
June 12 2015
Active Locations (1)
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1
Heart Institute haEmek Medical Center
Afula, Israel, 18101