ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
- Registration Number
- NCT00616460
- Lead Sponsor
- HaEmek Medical Center, Israel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
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 Criteria
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bivalirudin Bivalirudin -
- Primary Outcome Measures
Name Time Method End points: Primary :Major & minor bleeding Port of entry related complications 30 days
- Secondary Outcome Measures
Name Time Method End points: Secondary: 30 days MACE 30 days
Trial Locations
- Locations (1)
Heart Institute haEmek Medical Center
🇮🇱Afula, Israel
Heart Institute haEmek Medical Center🇮🇱Afula, Israel