ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding

HaEmek Medical Center, Israel

Status and phase

Completed

Phase 3

Conditions

Hematologic Diseases

Treatments

Drug: Bivalirudin

Study type

Interventional

Funder types

Other

Identifiers

NCT00616460

0124-07-EMC

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)