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

NCT ID: NCT00616460

Last Updated: 2015-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bivalirudin

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥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

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Turgeman Yoav

Chief of Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoav Turgeman, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute HaEmek medical center

Locations

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Heart Institute haEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0124-07-EMC

Identifier Type: -

Identifier Source: org_study_id

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