DRUG
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
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
Status
Completed
Phase
Phase 3
Enrollment
100
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 15, 2008
Study start
Feb 2008
Primary completion
Oct 2011
Study completion
Oct 2011
Results posted
Not reported
Registry updated
Jun 12, 2015
Outcomes
What the study measures.
Primary outcomes
End points: Primary :Major & minor bleeding Port of entry related complications
Time frame · 30 days
Secondary outcomes
End points: Secondary: 30 days MACE
Time frame · 30 days
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Israel. Showing up to 24 locations stored in the fast local snapshot.
Heart Institute haEmek Medical Center
Afula, Israel
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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