Hematologic Diseases
Conditions
Keywords
safety, efficacy
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.
Interventions
DRUGBivalirudin
Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT \< 250
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End points: Primary :Major & minor bleeding Port of entry related complications | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| End points: Secondary: 30 days MACE | 30 days |
Countries
Israel
Outcome results
None listed