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

Hematologic Diseases Clinical Trial

— ACRIPAB  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616460
• Other study ID #: 0124-07-EMC
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2008
• Last updated: June 11, 2015
• Start date: February 2008
• Est. completion date: October 2011

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

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

Locations

Country	Name	City	State
Israel	Heart Institute haEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End points: Primary :Major & minor bleeding Port of entry related complications		30 days	Yes
Secondary	End points: Secondary: 30 days MACE		30 days	Yes