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

This study is not yet open for participant recruitment.

Verified by HaEmek Medical Center, Israel, February 2008

First Received: February 5, 2008 Last Updated: February 14, 2008 History of Changes

Sponsored by:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00616460

Purpose

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.

Condition	Intervention	Phase
Hematologic Diseases	Drug: Bivalirudin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Bivalirudin

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

End points: Primary :Major & minor bleeding Port of entry related complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

End points: Secondary: 30 days MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616460

Contacts

Contact: Alexander Feldman, MD

972-4-6495275

feldman_al@clalit.org.il

Locations

Israel
Heart Institute haEmek Medical Center
Afula, Israel, 18101

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator:

Yoav Turgeman, MD

Heart Institute HaEmek medical center

More Information

No publications provided

Responsible Party:	Heart Institute, HaEmek Medical Center ( Dr Yoav Turgeman )
Study ID Numbers:	0124-07-EMC
Study First Received:	February 5, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00616460 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:

safety
efficacy

Study placed in the following topic categories:

Anticoagulants
Hematologic Diseases
Bivalirudin
Hemorrhage

Additional relevant MeSH terms:

Anticoagulants
Hematologic Diseases
Therapeutic Uses

Bivalirudin
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009