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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616460
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Turgeman Yoav, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment Phase
Hematologic Diseases Drug: Bivalirudin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders
Drug Information available for: Bivalirudin

Arm Intervention/treatment
Experimental: Bivalirudin 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

Primary Outcome Measures :
  1. End points: Primary :Major & minor bleeding Port of entry related complications [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. End points: Secondary: 30 days MACE [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616460

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Heart Institute haEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
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Principal Investigator: Yoav Turgeman, MD Heart Institute HaEmek medical center

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Responsible Party: Turgeman Yoav, Chief of Cardiology Department, HaEmek Medical Center, Israel Identifier: NCT00616460    
Other Study ID Numbers: 0124-07-EMC
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Turgeman Yoav, HaEmek Medical Center, Israel:
Additional relevant MeSH terms:
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Hematologic Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents