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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HaEmek Medical Center, Israel
• Treatments: Bivalirudin; Hirudins

Criteria

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)