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

Primary Purpose

Hematologic Diseases

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Bivalirudin
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Diseases focused on measuring safety, efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Heart Institute haEmek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bivalirudin

Arm Description

Outcomes

Primary Outcome Measures

End points: Primary :Major & minor bleeding Port of entry related complications

Secondary Outcome Measures

End points: Secondary: 30 days MACE

Full Information

First Posted
February 5, 2008
Last Updated
June 11, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00616460
Brief Title
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
Acronym
ACRIPAB
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
safety, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250
Primary Outcome Measure Information:
Title
End points: Primary :Major & minor bleeding Port of entry related complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
End points: Secondary: 30 days MACE
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Turgeman, MD
Organizational Affiliation
Heart Institute HaEmek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute haEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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